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

NCT04992845 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • Adolescent Idiopathic Scoliosis
  • Juvenile Idiopathic Scoliosis

Interventions

DEVICE

Anterior Vertebral Body Tethering

The SCOLI-TETHER (MIScoli) System is intended for anterolateral vertebral body fixation and internal fastening of the convex side of the thoracic curvatures thereby reducing the deformity and preventing the progression of idiopathic scoliosis in growing children/adolescents at high risk for curve progression while preserving motion.

Sponsors & Collaborators

  • Spino Modulation Inc.

    lead INDUSTRY

Principal Investigators

  • Firoz Miyanji · BC Children's

  • Kevin Smit · CHEO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992845 on ClinicalTrials.gov