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 Braiveâ„¢ GMS when used in the treatment of pediatric progressive scoliosis.
Who can participate
SexALL
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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…
What they're measuring
1
Summary of Device-related Adverse Events up to 24 Months