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Mainstay – ReActiv8 Study

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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.

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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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