Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 11:39 AM
Study NCT ID:
NCT03506334
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-11
First Post:
2018-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: