Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521814
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Globus Reflect Tether - HUD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Globus Reflect Tether - Humanitarian Use Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this device is to treat children and adolescents with scoliosis who have growth remaining In patients with a curvature about the spine Reflect holds the convexity of the curve in place so that the concavity can grow thereby harnessing the power of normal spine growth to correct the deformity
Detailed Description:
The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing Surgical correction is accomplished without spinal fusion instead utilizing anterior vertebral body tethering This device received an HDE exemption from the FDA and requires MUSC IRB approval to be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None