Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (NCT04929678) | Clinical Trial Compass
TerminatedNot Applicable
Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis
Stopped: The decision to early terminate the study was taken based on the achievement of all primary endpoints at 24-month for every active subjects. In addition, there are currently no plans to use the collected data to seek regulatory approval.
United States, Canada, United Kingdom10 participantsStarted 2021-08-12
Plain-language summary
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
A subject must meet all of the following inclusion criteria to participate in this study:
* Has a diagnosis of juvenile or adolescent idiopathic scoliosis
* Is skeletally immature with a Sanders Score of ≥2 to ≤5
* Has failed conservative care as per investigator's assessment
* Has a main thoracic Cobb angle between 30 and 60 degrees
* Has a Lenke Classification of 1A, 1B, or 1C
* Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative
* Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by Parent/legal guardian and/or patient/participant per local requirement.
Exclusion Criteria:
A subject will be excluded from participating in this study for any of the following reasons:
* Has undergone previous spinal fusion procedure(s) at the affected levels
* Is pregnant or plans to become pregnant within the first 24-months of the study
* Has a curve that requires instrumentation below L1
* Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord)
* Has any type of non-idiopathic scoliosis
* Has a left-sided curve
* Has an associated syndrome
* Has a history of malignant hyperthermia
* Has an active or significant risk of infection (immunocompromised)
* Has inadequate tissue coverage over the operative site as per investigator's assessment
* Has a suspected or documented allergy or intolerance to implant materials
* Has a major psychiatri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Summary of Device-related Adverse Events up to 24 Months