Braive™ GMS for Scoliosis
(BRAIVE IDE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
What data supports the effectiveness of the Braive™ Growth Modulation System (Braive™ GMS) treatment for scoliosis?
Research shows that a growth modulation system, similar to Braive™ GMS, helped 3 out of 6 patients with scoliosis by reducing the risk of their spine curving further compared to predictions if they were untreated. This suggests that the treatment may be beneficial in managing scoliosis progression.12345
Is the Braive™ Growth Modulation System safe for humans?
The Braive™ Growth Modulation System has been studied in early adolescent idiopathic scoliosis patients, and while the studies focus on effectiveness, they also provide safety insights. In a pilot study, the system was used in six patients, and no specific safety issues were reported. However, as with any surgical procedure, there may be risks, and further studies are needed to confirm long-term safety.12678
How is the Braive™ Growth Modulation System treatment different from other scoliosis treatments?
The Braive™ Growth Modulation System is unique because it uses a titanium implant to modulate spine growth, offering an alternative to traditional bracing or observation. This system is designed to reduce the risk of curve progression in scoliosis patients, particularly those who are highly skeletally immature, by providing a corrective force that encourages proper spinal alignment.127910
What is the purpose of this trial?
This trial aims to test the benefits and safety of the Braive™ GMS device in children with worsening scoliosis. The device helps straighten their spine and prevent further curvature.
Eligibility Criteria
This trial is for children and adolescents with juvenile or adolescent idiopathic scoliosis. They should have a main thoracic Cobb angle of 30-60 degrees, be skeletally immature (Sanders Score of 2-5), and not responded to conservative treatments. Participants must not have had prior chest surgery, spinal abnormalities, severe lung disease, or any condition that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Braive™ Growth Modulation System for the treatment of pediatric progressive scoliosis
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in spinal measurements
Treatment Details
Interventions
- Braive™ Growth Modulation System (Braive™ GMS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Spinal and Biologics
Lead Sponsor
Exponent, Inc.
Collaborator
Medical College of Wisconsin
Collaborator
Medical Metrics Diagnostics, Inc
Industry Sponsor
Syntactx
Collaborator