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Device

Braive™ GMS for Scoliosis (BRAIVE IDE Trial)

N/A
Waitlist Available
Research Sponsored by Medtronic Spinal and Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative
Has a diagnosis of juvenile or adolescent idiopathic scoliosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
Awards & highlights

BRAIVE IDE Trial Summary

This trial will test if the Braive™ GMS is safe and effective in treating pediatric progressive scoliosis.

Who is the study for?
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.Check my eligibility
What is being tested?
The Braive™ Growth Modulation System (Braive™ GMS) is being tested for its safety and potential benefits in treating progressive pediatric scoliosis. The study will assess how well this system can manage the curvature of the spine in young patients.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions to implant materials such as inflammation or infection at the site of surgery, discomfort from the device itself, and general surgical risks like bleeding.

BRAIVE IDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My spine curvature is less than or equal to 40 degrees.
Select...
I have been diagnosed with scoliosis since I was a child or teenager.

BRAIVE IDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pre-operative main thoracic Cobb angle compared to the post-operative Cobb angle at 24 months.
Number of secondary spinal surgeries defined as treatment failure up to 24 months postoperatively
Secondary outcome measures
Change from baseline in Neurological status at all available postoperative timepoints
Change from baseline in Pediatric Quality of Life Inventory™ (PedsQL) at all available postoperative timepoints
Change from baseline in Scoliosis Research Society-22 Patient Questionnaire (SRS-22) at all available postoperative timepoint
+11 more

BRAIVE IDE Trial Design

1Treatment groups
Experimental Treatment
Group I: Braive™ Growth Modulation System (Braive™ GMS)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Medtronic Spinal and BiologicsLead Sponsor
55 Previous Clinical Trials
10,578 Total Patients Enrolled
Exponent, Inc.UNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
Medical College of WisconsinOTHER
610 Previous Clinical Trials
1,162,519 Total Patients Enrolled

Media Library

Braive™ Growth Modulation System (Braive™ GMS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04929678 — N/A
Adolescent Idiopathic Scoliosis Research Study Groups: Braive™ Growth Modulation System (Braive™ GMS)
Adolescent Idiopathic Scoliosis Clinical Trial 2023: Braive™ Growth Modulation System (Braive™ GMS) Highlights & Side Effects. Trial Name: NCT04929678 — N/A
Braive™ Growth Modulation System (Braive™ GMS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929678 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the ultimate goals of this research endeavor?

"The primary outcome of this medical study, which takes place over a 24 month period post-surgery, is to assess the difference in pre and post operative thoracic Cobb angle. Secondary objectives include measuring the alteration from baseline on Pediatric Quality of Life Inventory™ (PedsQL), Scoliosis Research Society-22 Patient Questionnaire (SRS-22) as well as shoulder imbalance; all these metrics will be assessed at multiple time points during the trial."

Answered by AI

At what locations can participants access this clinical trial?

"Nicklaus Children's Hospital in Miami, IWK Health Centre in Halifax and Ascension Texas Spine and Scoliosis in Austin are the three main sites for this trial. Additionally, 6 other medical centres are participating as well."

Answered by AI

How many participants can this research project accommodate?

"The trial, conducted by Medtronic Spinal and Biologics, needs 25 suitable participants. It will be held at Nicklaus Children's Hospital in Miami, Florida as well as IWK Health Centre in Halifax, Nova Scotia."

Answered by AI

Are there any remaining vacancies in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this research effort is currently looking for potential subjects. It was initially listed on August 12th 2021 and has since received an update on November 30th 2022. 25 individuals need to be sourced from 6 different medical sites."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
< 18
What site did they apply to?
Ascension Texas Spine and Scoliosis
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Dec 2024