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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)
NCT04296903 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04296903
The ClinicalTrials.gov registry entry for NCT04296903 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Apifix, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04296903 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Missouri, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04296903?
The interventions under investigation include: MID-C System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04296903?
This trial is sponsored by Apifix, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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