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BioHealx® Anal Fistula Device Post Market Surveillance Study

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).

Conditions

Fistula-in-ano
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Related Conditions:

Fistula-in-ano

Study Overview

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Study Details

Study overview

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).

BioHealx® Anal Fistula Device Post Market Surveillance Study

BioHealx® Anal Fistula Device Post Market Surveillance Study

Condition
Fistula-in-ano
Intervention / Treatment

-

Contacts and Locations

Bryn Mawr

Maininle Health Lankenau, Bryn Mawr, Pennsylvania, United States, 19010

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Signum Surgical USA Inc.,

Study Record Dates

2026-12