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Braive™ GMS for Scoliosis (BRAIVE IDE Trial)
BRAIVE IDE Trial Summary
This trial will test if the Braive™ GMS is safe and effective in treating pediatric progressive scoliosis.
BRAIVE IDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBRAIVE IDE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BRAIVE IDE Trial Design
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Who is running the clinical trial?
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- I have had spinal fusion surgery at the affected levels.My spine curvature is less than or equal to 40 degrees.I cannot or will not follow up or follow instructions after surgery.I have been diagnosed with scoliosis since I was a child or teenager.I am at high risk for infections or have a weak immune system.I have had surgery on the same or opposite side of my chest before.I have a severe long-term lung condition.My doctor says I have weak bones that could affect surgery.
- Group 1: Braive™ Growth Modulation System (Braive™ GMS)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the ultimate goals of this research endeavor?
"The primary outcome of this medical study, which takes place over a 24 month period post-surgery, is to assess the difference in pre and post operative thoracic Cobb angle. Secondary objectives include measuring the alteration from baseline on Pediatric Quality of Life Inventory™ (PedsQL), Scoliosis Research Society-22 Patient Questionnaire (SRS-22) as well as shoulder imbalance; all these metrics will be assessed at multiple time points during the trial."
At what locations can participants access this clinical trial?
"Nicklaus Children's Hospital in Miami, IWK Health Centre in Halifax and Ascension Texas Spine and Scoliosis in Austin are the three main sites for this trial. Additionally, 6 other medical centres are participating as well."
How many participants can this research project accommodate?
"The trial, conducted by Medtronic Spinal and Biologics, needs 25 suitable participants. It will be held at Nicklaus Children's Hospital in Miami, Florida as well as IWK Health Centre in Halifax, Nova Scotia."
Are there any remaining vacancies in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research effort is currently looking for potential subjects. It was initially listed on August 12th 2021 and has since received an update on November 30th 2022. 25 individuals need to be sourced from 6 different medical sites."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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