All > Paid Studies Austin > Scoliosis

Braive™ Growth Modulation System (Braive™ GMS) for Adolescent Idiopathic Scoliosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ascension Texas Spine and Scoliosis, Austin, TXAdolescent Idiopathic Scoliosis+1 MoreBraive™ Growth Modulation System (Braive™ GMS) - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Juvenile Idiopathic Scoliosis
  • Adolescent Idiopathic Scoliosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 15 Secondary · Reporting Duration: Baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.

24 months.
Individual Subject Success
3 months.
Status of return to full activity within 3 months per Scoliosis Research Society-22 Patient Questionnaire (SRS-22)
Baseline to 24 months.
Change in pre-operative Cobb angle compared to the post-operative Cobb angle at 24 months.
Change in pre-operative main thoracic Cobb angle compared to the post-operative Cobb angle at 24 months.
Month 24
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
Month 24
Change from baseline in Neurological status at all available postoperative timepoints
Change from baseline in coronal balance at all available postoperative timepoints
Shoulder
Change from baseline in thoracic kyphosis at all available postoperative timepoints
Change from baseline in thoracolumbar/lumbar Cobb angle at all available postoperative timepoints
Change from baseline in total vertical spine height (T1-S1) at all available postoperative timepoints
Change from baseline in total vertical thoracic spine height (T1-T12) at all available postoperative timepoints
Baseline, immediately after the surgery, 3, 6, 12, 18, and annually until skeletal maturity is reached.
Change from baseline in Cobb angle at all available postoperative timepoints
Change from baseline in main thoracic Cobb angle at all available postoperative timepoints
Month 24
Number of device or procedure related adverse events up to 24 months
Month 24
Number of secondary spinal surgeries defined as treatment failure up to 24 months postoperatively
Number of secondary spinal surgeries not defined as treatment failure up to 24 months

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Braive™ Growth Modulation System (Braive™ GMS)
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Braive™ Growth Modulation System (Braive™ GMS) · No Placebo Group · N/A

Braive™ Growth Modulation System (Braive™ GMS)
Device
Experimental Group · 1 Intervention: Braive™ Growth Modulation System (Braive™ GMS) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 3, 6, 12, 18, 24 months, and annually until skeletal maturity is reached.

Who is running the clinical trial?

Exponent, Inc.UNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
Medtronic Spinal and BiologicsLead Sponsor
54 Previous Clinical Trials
9,587 Total Patients Enrolled
Medical Metrics Diagnostics, IncIndustry Sponsor
12 Previous Clinical Trials
1,703 Total Patients Enrolled
Medical College of WisconsinOTHER
572 Previous Clinical Trials
1,155,220 Total Patients Enrolled
SyntactxNETWORK
22 Previous Clinical Trials
1,147,358 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your spine has a curve between 30 and 60 degrees in your chest area.
You have been diagnosed with a type of scoliosis that starts during childhood or adolescence.
You have already tried other treatments as determined by the researcher, but they were not effective.
You have a specific type of spinal curvature called Lenke Classification 1A, 1B, or 1C.
Your spine is curved, but the curve is not severe enough to cause problems.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
< 18100.0%
What site did they apply to?
Ascension Texas Spine and Scoliosis100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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