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Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis | Clinical Trials | Clareo Health

TERMINATEDNA

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

NCT04929678•Medtronic Spinal and Biologics

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)
+9 more criteria

Locations (4)

Mayo Clinic

Rochester, Minnesota, United States

IWK Health Centre

Halifax, Nova Scotia, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Key Dates

Start Date

August 12, 2021

Primary Completion Date

April 11, 2025

Completion Date

January 14, 2026

Last Updated

March 20, 2026

Enrollment

ACTUAL participants

Conditions

Juvenile Idiopathic ScoliosisAdolescent Idiopathic Scoliosis

Interventions

Braive™ Growth Modulation System (Braive™ GMS)

DEVICE

Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis

NCT06365892

Adolescent Idiopathic Scoliosis (AIS)

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RECRUITINGNA

3D, Dynamic and Mechanically-informed Decision Making in AIS

NCT04761549

Adolescent Idiopathic Scoliosis

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RECRUITINGNA

Personalized Prevention and Treatment Strategies for Adolescent Idiopathic Scoliosis Via a Comprehensive Health Management Platform

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis

Inclusion Criteria

Exclusion Criteria

Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis

3D, Dynamic and Mechanically-informed Decision Making in AIS

Personalized Prevention and Treatment Strategies for Adolescent Idiopathic Scoliosis Via a Comprehensive Health Management Platform

Kids With Iron Deficiency and Scoliosis

Effect of Scapular Stabilization Exercises in Individuals With Adolescent Idiopathic Scoliosis

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