Braive™ Growth Modulation System (Braive™ GMS) for Adolescent Idiopathic Scoliosis
Study Summary
This trial will test if the Braive™ GMS is safe and effective in treating pediatric progressive scoliosis.
- Juvenile Idiopathic Scoliosis
- Adolescent Idiopathic Scoliosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 15 Secondary · Reporting Duration: Baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Braive™ Growth Modulation System (Braive™ GMS)
1 of 1
Experimental Treatment
25 Total Participants · 1 Treatment Group
Primary Treatment: Braive™ Growth Modulation System (Braive™ GMS) · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
Texas | 100.0% |
How old are they?
< 18 | 100.0% |
What site did they apply to?
Ascension Texas Spine and Scoliosis | 100.0% |
What portion of applicants met pre-screening criteria?
Met criteria | 100.0% |
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor