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NCT07021742 · ClinicalTrials.gov registry record
BioHealx® Anal Fistula Device Post Market Surveillance Study
A clinical trial of Fistula-in-ano, sponsored by Signum Surgical USA.
- Recruiting
- Registry status
- 50
- Enrollment target
- 2
- Study locations
NCT07021742: Recruiting study of Fistula-in-ano, sponsored by Signum Surgical USA.
NCT07021742 is a study of Fistula-in-ano that is actively recruiting participants, run by Signum Surgical USA. The registered enrollment target is 50 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07021742, a study of Fistula-in-ano, is actively recruiting participants, sponsored by Signum Surgical USA.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).
Primary Outcome
Successful closure repair of the anal fistula as determined by complete healing, i.e., internal and external opening closed (no evidence of an external opening present) without drainage
Conditions Studied
Interventions
- DEVICE BioHealx
Study Locations (2)
Florida
- The Colorectal Institute - Fort Myers
Pennsylvania
- Maininle Health Lankenau - Bryn Mawr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-06-14 |
| Est. Completion | 2026-12 |
What NCT07021742 shows while recruiting
NCT07021742 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 1 condition, with Fistula-in-ano appearing as the primary indexed condition, and to 1 intervention - of which BioHealx is the first listed.
NCT07021742 reports a single indexed study location in Florida, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07021742 about?
NCT07021742 is a clinical study titled "BioHealx® Anal Fistula Device Post Market Surveillance Study". This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).
What is the current status of trial NCT07021742?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2025-06-14. Estimated completion is 2026-12.
What conditions does trial NCT07021742 study?
This clinical trial studies the following conditions: Fistula-in-ano.
What interventions are being tested in trial NCT07021742?
The interventions under investigation include: BioHealx (DEVICE).
Who is sponsoring clinical trial NCT07021742?
This trial is sponsored by Signum Surgical USA, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07021742 being conducted?
This trial has 2 study locations across Florida, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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