Ignite Creation Date:
2025-12-18 @ 8:40 AM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT05998785
Status:
None
Last Update Posted:
2024-12-20 00:00:00
First Post:
2023-08-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Embody Insertional Achilles Tendinopathy
Sponsor:
None
Organization:
Study Overview
Official Title:
A Multi-Center, Prospective Case Series Evaluating Insertional Achilles Tendinopathy Repair Augmented with TAPESTRY® Biointegrative Implant
Status:
None
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative issues with IRB, none of which impacted the health/safety/welfare of the subjects, has resulted in enrollment suspension and subsequent study termination.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IAT
Brief Summary:
This study is a prospective case series of patients who have had insertional Achilles tendinopathy repair augmented with the Tapestry Biointegrative Implant. The primary aim of the study is to describe patient reported pain 12 months after surgical repair with Tapestry. The secondary aims are to assess the proportion of study subjects that experience treatment-related adverse events post-surgery, treatment related serious adverse events resulting in second surgical intervention, quality of life and other patient reported outcomes at all follow up timepoints post-surgery, and tissue thickness measured with MRI at 6 months post-surgery.
Detailed Description:
None
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?: