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NCT06298812 · ClinicalTrials.gov registry record · NA
REFLECT Scoliosis System Post Approval Study
A NA study of Idiopathic Scoliosis, sponsored by Globus Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT06298812: Recruiting NA study of Idiopathic Scoliosis, sponsored by Globus Medical.
NCT06298812 is a NA study of Idiopathic Scoliosis that is actively recruiting participants, run by Globus Medical. The registered enrollment target is 100 participants, below the 407-participant average among 3 other Idiopathic Scoliosis trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06298812, a NA study of Idiopathic Scoliosis, is actively recruiting participants, sponsored by Globus Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
Primary Outcome
Maintenance of major Cobb angle less than or equal to 40°
Conditions Studied
Interventions
- DEVICE REFLECT Scoliosis Correction System
Study Locations (2)
Minnesota
- Mayo Clinic - Rochester
New York
- New York University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-04-08 |
| Est. Completion | 2032-03-31 |
| Phase | NA |
What NCT06298812 shows while recruiting
NCT06298812 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 407-participant average among 3 other Idiopathic Scoliosis trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Idiopathic Scoliosis appearing as the primary indexed condition, and to 1 intervention - of which REFLECT Scoliosis Correction System is the first listed.
NCT06298812 reports a single indexed study location in Minnesota, New York.
Frequently Asked Questions
What is clinical trial NCT06298812 about?
NCT06298812 is a clinical study titled "REFLECT Scoliosis System Post Approval Study". The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
What is the current status of trial NCT06298812?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-04-08. Estimated completion is 2032-03-31.
What conditions does trial NCT06298812 study?
This clinical trial studies the following conditions: Idiopathic Scoliosis.
What interventions are being tested in trial NCT06298812?
The interventions under investigation include: REFLECT Scoliosis Correction System (DEVICE).
Who is sponsoring clinical trial NCT06298812?
This trial is sponsored by Globus Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06298812 being conducted?
This trial has 2 study locations across Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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