Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 10:03 PM
Study NCT ID:
NCT06113068
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2023-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fistura® Procedure for the Treatment of Complex Anal Fistulas
Sponsor:
F Care Systems NV
Organization:
Study Overview
Official Title:
Radiofrequency Using the Fistura® Procedure for the Treatment of Complex Anal Fistulas: Assessing Healing Rate and Anal Incontinence Up to 1 Year Follow-up
Status:
RECRUITING
Status Verified Date:
2025-02
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:
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
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?:
False
Is an FDA AA801 Violation?: