Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (BRAIVE IDE)

  • STATUS
    Recruiting
  • End date
    Dec 25, 2029
  • participants needed
    25
  • sponsor
    Medtronic Spinal and Biologics
Updated on 23 July 2022

Summary

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 of pediatric progressive scoliosis.

Details
Condition Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis
Treatment Braive™ Growth Modulation System (Braive™ GMS)
Clinical Study IdentifierNCT04929678
SponsorMedtronic Spinal and Biologics
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

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
Has a suspected or documented allergy or intolerance to implant materials
assessment
Has a major psychiatric disorder / history of drug abuse that would interfere with the
Is a ward of the court/state
Has had prior ipsilateral or contralateral chest surgery
subject's ability to comply with study instructions or might confound the study
Has severe chronic lung disease (e.g., asthma, bronchiectasis)
interpretation as per investigator's assessment (DSM-5 can be used as a reference)
Has poor bone quality, as determined by the investigator, that may limit anterior
fixation
Is unwilling or unable to return for follow-up visits and/or follow intra-operative
and/or postoperative instructions
Concurrent participation in another clinical study that may add additional safety
risks and/or confound study results
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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