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

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Medtronic

Status

Active, not recruiting

Conditions

Juvenile Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis

Treatments

Device: Braive™ Growth Modulation System (Braive™ GMS)

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT04929678
287046 (Other Identifier)
MDT19009SD1901

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Volunteers

No Healthy Volunteers

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 psychiatric disorder / history of drug abuse that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation as per investigator's assessment (DSM-5 can be used as a reference)
  • Is a ward of the court/state
  • Has had prior ipsilateral or contralateral chest surgery
  • Has severe chronic lung disease (e.g., asthma, bronchiectasis)
  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Braive™ Growth Modulation System (Braive™ GMS)
Experimental group
Treatment:
Device: Braive™ Growth Modulation System (Braive™ GMS)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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