Braive™ GMS for Scoliosis

(BRAIVE IDE Trial)

Not currently recruiting at 8 trial locations

Overseen By Katie Cameron

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Spinal and Biologics

Disqualifiers: Non-idiopathic scoliosis, Pregnancy, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-surgery to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Braive™ Growth Modulation System (GMS) for children and teens with progressive scoliosis, a condition where the spine curves sideways. The goal is to determine if the system is safe and effectively straightens the spine. The trial seeks participants diagnosed with juvenile or adolescent idiopathic scoliosis who have not had success with other treatments and have a specific range of spinal curvature. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to innovative solutions for scoliosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that the Braive™ Growth Modulation System is safe for treating pediatric progressive scoliosis?

Research has shown that the Braive™ Growth Modulation System (GMS) has been tested on a small group of children with worsening scoliosis. An initial study with six patients found no specific safety problems, suggesting that the Braive™ GMS is generally safe. As this trial aims to determine the system's benefits and safety, the absence of safety concerns is encouraging. However, larger studies are needed to confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Braive™ Growth Modulation System (Braive™ GMS) because it offers a new approach to treating scoliosis. Unlike traditional treatments like braces or surgery, which can be uncomfortable and invasive, Braive™ GMS is designed to modulate growth in a way that corrects spinal curvature more naturally. This system targets the growth plates, aiming to guide the spine's development over time, potentially reducing the need for more aggressive interventions. This innovative mechanism could mean less discomfort and a more effective long-term solution for patients with scoliosis.

What evidence suggests that the Braive™ GMS is effective for scoliosis?

Research has shown that the Braive™ Growth Modulation System (GMS) might help treat children with worsening scoliosis. This system guides the spine's growth to reduce its curve. Early results suggest it can effectively straighten the spine as children grow. Recent studies have focused on its safety and initial success, and the device appears promising in managing scoliosis without requiring more invasive treatments. Although more information is needed, the Braive™ GMS offers a hopeful new option for children with scoliosis. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Has a main thoracic Cobb angle between 30 and 60 degrees

Is skeletally immature with a Sanders Score of ≥2 to ≤5

Has a Lenke Classification of 1A, 1B, or 1C

Exclusion Criteria

Has an associated syndrome

Has a history of malignant hyperthermia

Has any type of non-idiopathic scoliosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Braive™ Growth Modulation System for the treatment of pediatric progressive scoliosis

Immediate post-surgery to 24 months

Regular follow-up visits at 3, 6, 12, 18, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in spinal measurements

24 months and annually until skeletal maturity

Annual visits until skeletal maturity

What Are the Treatments Tested in This Trial?

Interventions

• Braive™ Growth Modulation System (Braive™ GMS)

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Medtronic Spinal and Biologics

Lead Sponsor

Trials

56

Recruited

10,600+

Exponent, Inc.

Collaborator

Trials

2

Recruited

210+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Medical Metrics Diagnostics, Inc

Industry Sponsor

Trials

14

Recruited

1,800+

Syntactx

Collaborator

Trials

23

Recruited

1,147,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04929678

NCT04929678 | Study of the Braive Growth Modulation ... 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 ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT04929678

Study of the Braive Growth Modulation System for Progressive ... The purpose of this study is to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment ...

3. ctv.veeva.com ctv.veeva.com/study/study-of-the-braive-growth-modulation-system-for-progressive-pediatric-scoliosis

Study of the Braive Growth Modulation System for Progressive ... The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used ...

4. withpower.com withpower.com/trial/phase-scoliosis-7-2021-804c2

Braive™ GMS for Scoliosis · Info for Participants What data supports the effectiveness of the Braive™ Growth Modulation System (Braive™ GMS) treatment for scoliosis? Research shows that a growth modulation ...

5. medicaldevice-network.com medicaldevice-network.com/news/medtronic-braive-trial/

Medtronic evaluates Braive growth modulation system in ... The prospective, multi-centre BRAIVE IDE trial will assess the safety and effectiveness of the growth modulation system in correcting the curve of the spine.

6. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/braive-ide-study/

BRAIVE-IDE study The purpose of this study is to evaluate the Braive™ Growth Modulation System (GMS)(or “Study Device”) to see if it is safe and beneficial when used in the ...