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New device aims to straighten spines in kids without surgery

NCT ID NCT04929678

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

10 people

The number who actually took part.

Started

Aug 2021

Finished

Jan 2026

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • 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.