REFLECT Scoliosis System Post Approval Study

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Globus Medical Inc
Study ID
NCT06298812
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Scoliosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • REFLECT Scoliosis Correction System — DEVICE
    The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials.

Study Details

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

Key Dates

Start date
Apr 8, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2032

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: REFLECT
    Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device.

Primary Outcome Measure

Primary Probable Benefit [ Time Frame: 60 months postoperative ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Angie Severson
Noelle Larson, MD (PRINCIPAL_INVESTIGATOR)
New York UniversityNew YorkNew York10016-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNNew York University· New York, NY

Related Studies