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NCT04296903 · ClinicalTrials.gov registry record · NA
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
A NA study of Adolescent Idiopathic Scoliosis, sponsored by Apifix.
- Active
- Registry status
- NA
- Development phase
- 201
- Enrollment target
- 14
- Study locations
NCT04296903: Active NA study of Adolescent Idiopathic Scoliosis, sponsored by Apifix.
NCT04296903 is a NA study of Adolescent Idiopathic Scoliosis that is active but no longer recruiting, run by Apifix. The registered enrollment target is 201 participants, below the 249-participant average among 7 other Adolescent Idiopathic Scoliosis trials with a reported enrollment target (19% lower). The trial reports 14 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04296903, a NA study of Adolescent Idiopathic Scoliosis, is active but no longer recruiting, sponsored by Apifix.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 201 participants
- Enrollment target
- 14
- Study locations
Study Summary
The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.
Primary Outcome
Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated
Conditions Studied
Interventions
- DEVICE MID-C System
Study Locations (14)
Missouri
- Women and Children's Hospital - University of Missouri Health Care - Columbia
- Shriners Hospitals for Children - St Louis
Ohio
- Rainbow babies and children - Cleveland
- Dayton Children's Hospital - Dayton
California
- Rady Children's Hospital - San Diego
Florida
- Wolfson children's hospital - Jacksonville
Georgia
- Wellstar - Atlanta
Indiana
- Riley Children's Health - Indianapolis
Kansas
- Children's Mercy Hospital - Kansas City
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2020-05-31 |
| Est. Completion | 2030-06-30 |
| Phase | NA |
What the registry record for NCT04296903 still lists
NCT04296903 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 249-participant average among 7 other Adolescent Idiopathic Scoliosis trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Adolescent Idiopathic Scoliosis appearing as the primary indexed condition, and to 1 intervention - of which MID-C System is the first listed.
NCT04296903 lists 14 locations in 12 states (Missouri, Ohio, California).
Frequently Asked Questions
What is clinical trial NCT04296903 about?
NCT04296903 is a clinical study titled "Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)". The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to ac...
What is the current status of trial NCT04296903?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 201 participants. The study started on 2020-05-31. Estimated completion is 2030-06-30.
What conditions does trial NCT04296903 study?
This clinical trial studies the following conditions: Adolescent Idiopathic Scoliosis.
What interventions are being tested in trial NCT04296903?
The interventions under investigation include: MID-C System (DEVICE).
Who is sponsoring clinical trial NCT04296903?
This trial is sponsored by Apifix, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04296903 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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