New device aims to straighten spines in kids without surgery
NCT ID NCT04929678
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a device called the Braive Growth Modulation System in 10 children with scoliosis (curved spine). The goal was to see if it could safely correct the curve as the child grows. The study was stopped early, so results are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
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IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary
Newcastle upon Tyne, NE7 7DN, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can simple yoga poses straighten curved spines in children?
- Can 3D scans and muscle sensors unlock scoliosis secrets?
- Virtual reality could transform scoliosis therapy for teens
- Can a Night-Time brace or targeted exercises halt scoliosis curves in teens?
- Could a sweet drink before surgery speed up recovery?
- Could an extra spinal cut straighten scoliosis better?