Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-28 @ 8:07 AM
Study NCT ID:
NCT02831868
Status:
UNKNOWN
Last Update Posted:
2018-09-04
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
Multi Center, Open-label, Single Arm, Study Designed to Evaluate Safety, Tolerability and Efficacy of HAVAI, a Minimally Invasive Implant Composed of Spring, Double Anchor and Suture, Versus Standard of Care 1st Metatarsal Osteotomy, for Correction of Inter-metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
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:
A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: