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Recruiting No phase listed Observational

BioHealx® Anal Fistula Device Post Market Surveillance Study

ClinicalTrials.gov ID: NCT07021742

Public ClinicalTrials.gov record NCT07021742. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 8:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT07021742
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Signum Surgical USA Inc.
Industry
Enrollment
50 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 13, 2025
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026
Last update posted
Jun 2, 2026

2025 – 2026

United States locations

U.S. sites
6
U.S. states
4
U.S. cities
6
Facility City State ZIP Site status
The Colorectal Institute Fort Myers Florida 33912 Recruiting
Hackensack University Medical Center Hackensack New Jersey 07601 Recruiting
Weill Cornell Medicine New York New York 10021 Recruiting
Northwell Health Staten Island New York 10305 Recruiting
Maininle Health Lankenau Bryn Mawr Pennsylvania 19010 Recruiting
Geisinger Danville Pennsylvania 17822 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07021742, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 2, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07021742 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →