TerminatedNot Applicable

Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period

Stopped: The Sponsor decided to focus their resources on the clinical data collection for the second generation of the investigational device.

Canada44 participantsStarted 2019-04-15

Plain-language summary

The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.

Who can participate

Age range

9 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of juvenile or adolescent idiopathic scoliosis
. Male and female subjects greater than 8 years of age with significant growth remaining
. Risser Stage 0 or 1
. Subjects should have at least three years of estimated growth remaining based on Risser staging
. Major thoracic scoliosis with Cobb Angle \> 40° and \< 70° and Lenke I, II or V curve pattern. Cobb measurements refer to measures taken without a brace. Patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure
. Thoracic kyphosis (T5-T12) \< 50°
. Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of device- &/or procedure-related SAEs

Timeframe: 12 months

Change in Cobb angle measurement

Timeframe: 12 months

Trial details

NCT IDNCT04992845

SponsorSpino Modulation Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-01

View on ClinicalTrials.gov More Adolescent Idiopathic Scoliosis trials

Who can participate

Age range

9 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of juvenile or adolescent idiopathic scoliosis
. Male and female subjects greater than 8 years of age with significant growth remaining
. Risser Stage 0 or 1
. Subjects should have at least three years of estimated growth remaining based on Risser staging
. Major thoracic scoliosis with Cobb Angle \> 40° and \< 70° and Lenke I, II or V curve pattern. Cobb measurements refer to measures taken without a brace. Patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure
. Thoracic kyphosis (T5-T12) \< 50°
. Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive)

Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria