Trials / Terminated
TerminatedNCT04929678
Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis
A Prospective, Multi-Center Study of the Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed With Juvenile or Adolescent Idiopathic Scoliosis
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Braive™ Growth Modulation System (Braive™ GMS) | The Braive™ GMS is designed as a growth-modulation, non-fusion technique, which utilizes patients' remaining growth potential to limit further progression of the curve, to provide correction of the thoracic spine, and allow continued growth while maintaining mobility. The system consists of the following components: Braid, Fixed Angle Screws (FAS), Plate, and Break-Off Set Screw. |
Timeline
- Start date
- 2021-08-12
- Primary completion
- 2025-04-11
- Completion
- 2026-01-14
- First posted
- 2021-06-18
- Last updated
- 2026-03-20
- Results posted
- 2026-03-20
Locations
4 sites across 3 countries: United States, Canada, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04929678. Inclusion in this directory is not an endorsement.