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The ReActiv8® Clinical Study Study Overview

What is ReActiv8®?

ReActiv8 is a surgically-implanted device that uses mild electrical stimulation to activate the key stabilizing muscles of the lower back. Similar to exercise programs used to restore muscle control, ReActiv8 stimulation is delivered twice a day for about 30 minutes. You control when to start and stop each stimulation session via a handheld wireless remote control. Over time, ReActiv8 is designed to help your body regain control over the muscles that provide lower back stability, which may help relieve chronic low back pain.

ReActiv8 is placed through a minimally invasive, reversible surgical procedure. Your doctor will make a small incision to place thin wires, called leads, on either side of your spine. The leads connect to a small pulse generator (about the size of a matchbox). The pulse generator is implanted just below the skin, normally in the upper buttock.

About the ReActiv8® Clinical Study

Right now, doctors at select centers throughout the U.S. are accepting participants for a new clinical study to evaluate ReActiv8 for the treatment of chronic low back pain. If you qualify and choose to participate in the study, you will receive the ReActiv8 system and all study-related care at no cost.

Step 1:

Screening/Baseline To see if you might be eligible for the ReActiv8 Study, the first step is the Screening/Baseline evaluation. During this evaluation, your study doctor will perform a routine physical exam and will ask you about past medications and treatments for your back pain. You will also complete several questionnaires to measure the severity of your pain and its impact on your quality of life. If you pass the Screening/Baseline evaluation and wish to continue with the study, you will be scheduled to have the ReActiv8 system implanted.

Step 2:

ReActiv8 Implant Procedure & Activation ReActiv8 is placed through a minimally-invasive, reversible surgical procedure (performed under local or general anesthesia). On average, the procedure takes about 1 – 2 hours, and you may remain in the hospital overnight and go home the day after.

Approximately 7 to 14 days after the ReActiv8 system is implanted, you will return to your study doctor’s office to have the system turned on (activated). As part of the ReActiv8 study, you will be randomly assigned (like a coin flip) to either the Treatment Group or the Control Group. If you are assigned to the Treatment Group (50% chance), your ReActiv8 device will be set to deliver stimulation at an appropriate level for your circumstances. If you are assigned to the Control Group (50% chance), your device will be set to deliver only minimal stimulation. You will not be told to which group you were assigned until approximately 4 months after activation. However, if you were originally assigned to the Control Group, you will be given the option at this stage to “crossover” to the Treatment Group.

Step 3:

Follow-Up Visits Following activation of your ReActiv8 device, you will be asked to return to your study doctor’s office about 8 times over a 1-year period, and then once a year thereafter (up to a maximum of 6 years). These visits are an important part of the study, as they allow your study doctor to closely monitor your individual results and experiences. During these visits, the settings of your ReActiv8 device will be reviewed, and may be adjusted as needed.

The ReActiv8® Clinical Study Frequently Asked Questions

1. What is the purpose of a clinical study?

Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of possible new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

2. How is ReActiv8® designed to work?

ReActiv8 is a surgically-implanted device that uses mild electrical stimulation to activate the key stabilizing muscles of the lower back. Similar to exercise programs used to restore muscle control, ReActiv8 stimulation is delivered twice a day for about 30 minutes. You control when to start and stop each stimulation session via a handheld wireless remote control. Over time, ReActiv8 is designed to help your body regain control over the muscles that provide lower back stability, which may help relieve chronic low back pain.

3. How do I conduct my ReActiv8 stimulation sessions?

You will be asked to apply stimulation to your back two times a day, each time for about 30 minutes. You will be asked to do this while you lie down on your side or your stomach. It is recommended you conduct your sessions about same time every day, with one time in the morning and one time in the evening.

4. Are there any costs involved in the ReActiv8® Study?

If you choose to join the ReActiv8 Study, you will receive all study-related care at no cost. This includes the ReActiv8 system and procedure, as well as any study visits to your study doctor’s office. You may also be compensated for travel expenses to attend study visits.

5. Why is there a Control Group?

To test a new treatment it’s important for researchers to be as certain as possible that any changes are because of the new treatment. The best way to do this is to have two groups that have the same characteristics and undergo the same care, except for the new treatment being studied.

6. Who is sponsoring the study?

The study is being sponsored by MML US, Inc. (www.mainstay-medical.com), a global medical device company with offices in the US, Australia, and Ireland.

7. How do I know if I am eligible for the ReActiv8 Clinical Study?

If you struggle with chronic low back pain and have not received lasting relief through medications and physical therapy, you may qualify the ReActiv8 Clinical Study. If you are interested in possibly participating in the study, your study doctor and team will help see if you meet the study criteria.

Thank you for your interest in the ReActiv8 Clinical Study. Please contact us if you have any questions.

Coordinator Name

Site Name

Coordinator Phone

Coordinator Email

CAUTION – Investigational device. Limited by Federal (or United States ) law to investigational use. © 2016 Mainstay Medical Limited. All rights reserved. ReActiv8®

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You may be suffering from Lumbar Spinal Stenosis, and may be eligible for a minimally invasive treatment.
www.vertiflexspine.com 866.268.6486 | info@vertiflexspine.com
Vertiflex and Superion are registered trademarks of Vertiflex. © 2016 Vertiflex All rights reserved.
VF-LD-0094 Rev A
Take back your life.
Are you suffering from?
FDA approved for the treatment of lumbar spinal stenosis.
Contact your physician for more information on this minimally invasive procedure.
You may also visit us at www.vertiflexspine.com
Indirect Decompression System
What is Lumbar Spinal Stenosis?
Spinal stenosis is the narrowing of the passageways (or canals) in the spine. These canals protect the spinal cord and the nerves that travel to and from the spinal column. When stenosis occurs in the lower (or lumbar) spine, patients may suffer from pain, numbness, and/or cramping in the legs when walking or standing. Spinal stenosis is most often caused by age-related changes that take place over time. What is Superion®?
The Superion Indirect Decompression System (IDS) is a spinal implant designed to treat symptoms of moderate degenerative lumbar spinal stenosis. This device is implanted by minimallyinvasive methods through a cannula and received FDA approval for commercialization.
Your physician will gain access to the affected area through a small cannula (fig. 1).
The appropriately sized implant is then delivered (fig. 2).
The surgical site is then closed (fig. 3).
Who is Vertiflex®?
Vertiflex is a company founded in 2005 and located in Southern California. Our focus is on innovative minimally invasive treatments for lumbar spinal stenosis. We are committed to excellence and continue to gather clinical data on the safety and efficacy of the Superion IDS. We are partnering with physicians to gather evidence documenting the performance and clinical outcomes of the Superion implant with the ultimate goal of giving patients back their lives. Why should I consider participating in this registry?
You may consider this evaluation if your doctor has diagnosed you with lumbar spinal stenosis, and if the following applies to you:
• Persistent leg/buttock/groin pain, with or without back pain that is relieved by activities such as sitting or bending over a shopping cart • 45 years of age or older • Have tried non-operative treatment of your pain for at least six months
What are my responsibilities if I join?
If you join the registry, you will be enrolled for approximately 12 months. Patients included in the clinical registry will return for follow-up visits at 3 weeks, and 6 and 12 months post-treatment to collect data for the primary evaluation.
How does it work?
Superion is implanted between the spinous processes (the bony projections off the back of each vertebra) through a tube that is approximately the diameter of a dime. The device is designed to limit extension at the symptomatic level while preserving mobility and structural elements. Superion may help to widen the narrowed passageways, potentially resulting in relief of the pain caused by the compression of the neural structures in extension (when standing or walking).

This can be an outpatient procedure. Average operating time is 30 minutes, under monitored anesthesia care (MAC) with minimal blood loss.
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FREQUENTLY ASKED QUESTIONS
How does the procedure work? There is a temporary trial procedure, or a “test drive,” which usually lasts 5-7 days. If this successfully reduces your pain, you and your doctor will discuss a more permanent implant.
Will I feel anything? You should not feel anything. Unlike traditional spinal cord stimulation systems, HF10 therapy does not create a tingling or buzzing sensation, known as paresthesia.
Is the trial procedure reversible? Yes, the leads can be easily removed.
Can I turn the device off if I need to? Yes, you will have control over your threapy and can turn it off using your trial stimulator or remote control.
Can I travel with an SCS system? Traveling is simple and easy for SCS patients. If the patient needs to go through a security screening device, such as those found at the airport, he or she should request assistance to bypass the screening device since they have an implanted device.
For more information on HF10 therapy, talk to your doctor.

KEY CRITERIA
Have you experienced pain in your upper limb(s) from any one of the following conditions?
• Cervical fusion surgery • Diabetic neuropathy • Brachial plexus stretch/avulsion injury • Complex regional pain syndrome (CRPS) or Reflex sympathetic dystrophy (RSD)? Are you 18 years of age or older as of today?
IF YOU HAVE ANSWERED YES TO THE QUESTIONS ABOVE, YOU MAY BE INTERESTED IN TAKING PART IN A RESEARCH STUDY FOR YOUR ARM OR LEG PAIN.
For more information or to find out if this study is suitable for you, please contact the investigator below:
PI Name Address Phone Number Ask for Contact

References: 1. Smet I, Van Buyten JP, Al-Kaisy A. European Prospective Study with the Nevro Implantable System. Presentation at North American Neuromodulation Society 2010 Meeting. 2. Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. (2014, eprint 2013). Sustained Effectiveness of 10 kHz High-Frequency Spinal Cord Stimulation for Patients with Chronic, Low Back Pain: 24-Month Results of a Prospective Multicenter Study. Pain Medicine 2014; 15: 347-354
3. Kapural L, Gliner B, Amirdelfan K, Yearwood T, & Yang T. (2015). Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain. Anesthesiology, 123(4). Indications of Use: Nevro’s Senza SCS system is intended to aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Failed back surgery syndrome, intractable low back pain, leg pain. Contraindications: Nevro’s Senza SCS system should not be used if: You are unable to operate the spinal cord stimulation system. You are a poor surgical risk. Warnings, precautions and side effects: Refer to the Patient Manual prior to use and consult your physician.
STUDY
A multi-center, prospective, clinical trial of the Senza® Spinal Cord Stimulation (SCS) system in the treatment of chronic pain of the upper extremities

OVERVIEW OF SCS SYSTEM
The key components of a rechargeable SCS system are leads, an implantable pulse generator (IPG), patient remote control, and a portable charging system.
• LEADS: Thin wires that deliver precise pulses from the IPG to the spinal cord.
• IMPLANTABLE PULSE GENERATOR (IPG): A small, implantable device that features a rechargeable battery and other electronics that deliver the pulses to the leads. The pulse generator is placed surgically under the skin, usually in the buttock or the abdomen.
• REMOTE CONTROL: Allows the patient to turn the system on and off and adjust stimulation within parameters set by physicians.
• CHARGER: The mobile charger is used by the patient to recharge the IPG battery after it is implanted.
BACKGROUND ON CHRONIC PAIN AND SPINAL CORD STIMULATION
If you suffer from pain, you are not alone. Pain is the most common reason for physician visits in Europe and the United States. Living with severe pain can significantly interfere with your quality of life. There are many treatment options for chronic pain and your physician may recommend different treatments depending on the type of pain and severity of pain.
Spinal cord stimulation (SCS) is a proven therapy that offers a treatment option for chronic pain. SCS uses electrical pulses to interrupt pain signals, resulting in pain relief. Hundreds of thousands of people with chronic pain have received relief with spinal cord stimulation.
NEVRO’S SENZA SYSTEM, DELIVERING HF10™ THERAPY
Nevro’s Senza spinal cord stimulation (SCS) system, delivering HF10 therapy, is intended to aid in the management of chronic intractable pain of the trunk and/or limbs. Through numerous clinical studies, HF10 therapy demonstrated a number of key benefits.1,2
• Significant reduction in pain of the trunk and/or limbs.
• Pain relief without paresthesia, a buzzing sensation that traditional SCS systems generate in order to provide pain relief. Majority of patients find the buzzing sensation uncomfortable.
• Reduction of opiod use.
This investigational study is evaluating the Senza SCS system to treat subjects with chronic pain of the upper extremities.
HF10 THERAPY PROCEDURE OVERVIEW
TRIAL PHASE
SCS therapy offers an evaluation period: a candidate for SCS can test-drive the therapy during the evaluation period using a temporary external system.
To trial the therapy, a minor surgical procedure will be performed to place the leads in the back. The leads are then connected to an external pulse generator that is worn on a belt typically for 5-7 days (usually no more than 14 days). During this period, the system’s programs are adjusted to best alleviate the patient’s pain.
After the trial, the candidate will report to the doctor how much pain relief was felt. Together, the candidate and doctor can decide if SCS therapy is something they would like to continue to receive.
PERMANENT PHASE
If you and your doctor decide to proceed with SCS, receiving an SCS implant is the next step. This requires another minor, reversible surgical procedure to place the implantable pulse generator (IPG), beneath the skin.

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Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)

This study is enrolling participants by invitation only.

Sponsor:

Holy Cross Hospital, Florida

Information provided by (Responsible Party):

Holy Cross Hospital, Florida

ClinicalTrials.gov Identifier: NCT02948049

Purpose

This study is a single site, prospective, observational trial utilizing a wrist-worn accelerometer to evaluate clinical outcomes of SCS and PNS in the treatment of chronic pain.

Condition
Chronic Pain
Back Pain
Neck Pain
Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)

Further study details as provided by Holy Cross Hospital, Florida:

Primary Outcome Measures:

  • Assess whether there is an increase in objective measurements of physical function in subjects after treatment with an FDA-approved spinal cord stimulation device (SCS) or FDA-approved peripheral nerve stimulation (PNS) device compared with pre-implant. [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]

A subject is considered to have met the primary objective if there is a statistically significant (p value < .05) increase in physical function.

Secondary Outcome Measures:

  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer in subjects correlate with an improvement in subjective assessments as measured by the Numeric Rating Scale (NRS). [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer in subjects correlate with an improvement in subjective assessments as measured by the Short Form-36 Health Survey (SF-36). [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer in subjects correlate with an improvement in subjective assessments as measured by the Oswestry Disability Index (ODI). [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]
  • Determine if an increase in physical function obtained from objective assessments of data recorded by the wrist-wornaccelerometer in subjects correlate with an improvement in subjective assessments as measured by the Neck Disability Index (NDI). [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]

Other Outcome Measures:

  • Evaluate the relationship between physical function and/or pain in subjects stratified into subgroups based on descriptive variables. [ Time Frame: Pre-implant to 8 weeks post permanent implant ] [ Designated as safety issue: No ]
Estimated Enrollment: 150
Study Start Date: October 2016
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

Detailed Description:

Up to 150 evaluable subjects will be recruited at this site on an ongoing basis. Evaluable subjects are defined as subjects that complete the End of Study visit. Each subject will be assigned an accelerometer and have data recorded for a seven-day period pre-implant trial to collect baseline data. The accelerometer will also be worn during the trial for a period of up to seven (7) days. If the trial is successful and the subject is implanted, the subject will wear the accelerometer for a seven-day period at least six (6) weeks post-permanent implant. The following assessments will be administered to subjects at the baseline (pre-implant trial) visit, the end of implant trial visit and the end of study visit (8 weeks post-permanent implant): the Numerical Rating Scale (NRS) 11-point scale for pain; the SF-36 Health Survey; the Oswestry Disability Index (ODI). Subjects treated for neck pain will also complete the Neck Disability Index (NDI). Additionally, the subjects will be asked to complete a subject diary to record average daily NRS scores for days the accelerometer is worn.

Eligibility

Ages Eligible for Study: 18 Years and older   (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample

Study Population

The subjects recruited for this study will be representative of the population of subjects with chronic pain and a candidate for SCS or PNS trial. Subjects recruited for this study must be 18 years of age or older. It is anticipated that approximately equal numbers of males and females will be recruited. No subjects will be excluded based upon his/her race or ethnicity.

Criteria

Inclusion Criteria:

Subjects enrolled in this study must meet the following criteria:

  1. Subject is 18 years of age or older
  2. Subject is a candidate for on label use of a SCS or PNS device
  3. Subject is ambulatory
  4. Subject is able to understand and willing to comply with study procedures and requirements
  5. Subject is able to provide informed consent to participate in the study

Exclusion Criteria:

Subjects will be excluded from participation in this study if they meet any one of the following criteria:

  1. Subject has comorbidities that, in the judgment of the investigator, may confound the reliability of the information acquired in this study
  2. In the judgment of the investigator, the subject is not seeking an improvement in physical function as a treatment goal of SCS or PNS

current researchCurrent Researchtriangle  Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02948049

Sponsors and Collaborators
Holy Cross Hospital, Florida
Investigators
Principal Investigator: William P McRoberts, MD Holy Cross Hospital, FL

current researchCurrent Researchtriangle  More Information

Additional Information:

Publications:

  1. Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. Review.
  2. Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967 Jul-Aug;46(4):489-91.
  3. Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O’Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008 Oct;63(4):762-70; discussion 770. doi: 10.1227/01.NEU.0000325731.46702.D9.
  4. Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Review.
  5. Perruchoud C, Buchser E, Johanek LM, Aminian K, Paraschiv-Ionescu A, Taylor RS. Assessment of physical activity of patients with chronic pain. Neuromodulation. 2014 Jun;17 Suppl 1:42-7. doi: 10.1111/ner.12036. Review.
  6. Paraschiv-Ionescu A, Perruchoud C, Buchser E, Aminian K. Barcoding human physical activity to assess chronic pain conditions. PLoS One. 2012;7(2):e32239. doi: 10.1371/journal.pone.0032239.
  7. Huang KT, Martin J, Marky A, Chagoya G, Hatef J, Hazzard MA, Thomas SM, Lokhnygina Y, Lad SP. A national survey of spinal cord stimulation trial-to-permanent conversion rates. Neuromodulation. 2015 Feb;18(2):133-9; discussion 139-40. doi: 10.1111/ner.12199.
  8. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT.. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. Review.
  9. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
  10. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review.
  11. Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum in: J Manipulative Physiol Ther 1992 Jan;15(1):followi.

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