RECRUITING

BioHealx® Anal Fistula Device Post Market Surveillance Study

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

BioHealx® Anal Fistula Device Post Market Surveillance Study

Quick Facts

Study Start:2025-06-14

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07021742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18 - 75 years * Presence of Single Continuous Anal Fistula presenting for initial curative surgery * Failed or Recurrent Anal Fistula Closure * Minimum of 6-weeks of draining seton placed prior to procedure. * Availability for follow-up contacts and willingness to complete the Informed Consent.	* Fistula tract shorter than 2cm * Complex fistula tract (branching) * Body Mass Index \> 35 * Known uncontrolled diabetes or other systemic condition associated with impaired healing * Known HIV-positive or immunocompromised * Rectal prolapse * Pregnancy * Rectal / fistula malignancy * Crohn's disease * Ulcerative proctitis * Hidradenitis suppurativa of the anal region * Pilonidal sinus disease * Presence of hemorrhoid Involving fistula site * Continuous use of anti-inflammatory * Intersphincteric fistula in ano or fistula treatable by simple fistulotomy * Active infection or abscess involving fistula site * Known allergy to PLGA material * Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study * Treatment with an investigational drug or medical device in the past 30 days

Inclusion Criteria

Exclusion Criteria

* Age 18 - 75 years
* Presence of Single Continuous Anal Fistula presenting for initial curative surgery
* Failed or Recurrent Anal Fistula Closure
* Minimum of 6-weeks of draining seton placed prior to procedure.
* Availability for follow-up contacts and willingness to complete the Informed Consent.

* Fistula tract shorter than 2cm
* Complex fistula tract (branching)
* Body Mass Index \> 35
* Known uncontrolled diabetes or other systemic condition associated with impaired healing
* Known HIV-positive or immunocompromised
* Rectal prolapse
* Pregnancy
* Rectal / fistula malignancy
* Crohn's disease
* Ulcerative proctitis
* Hidradenitis suppurativa of the anal region
* Pilonidal sinus disease
* Presence of hemorrhoid Involving fistula site
* Continuous use of anti-inflammatory
* Intersphincteric fistula in ano or fistula treatable by simple fistulotomy
* Active infection or abscess involving fistula site
* Known allergy to PLGA material
* Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study
* Treatment with an investigational drug or medical device in the past 30 days

Contacts and Locations

Study Contact

Katy Feeny

CONTACT

610-860-6577

kjclinconsulting@gmail.com

Study Locations (Sites)

Maininle Health Lankenau

Bryn Mawr, Pennsylvania, 19010

United States

Collaborators and Investigators

Sponsor: Signum Surgical USA Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-14

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-06-14

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Fistula-in-ano