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Recruiting NCT07021742

BioHealx® Anal Fistula Device Post Market Surveillance Study

— Observational Fistula-in-ano

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BioHealx.
Who it may be relevant to
Registry conditions: Fistula-in-ano. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

Interventions

  • Device BioHealx
    Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device, a bioabsorbable implant designed to securely close the fistula internal opening, preventing reinfection, while allowing for drainage through the external opening during healing.

Primary outcome measures

  • Successful Closure Repair [Time frame: 12 Months]
  • Non-Recurrence Incidence [Time frame: 24 and 36 Months]
Secondary outcome measures (5)
  • Fecal Incontinence Quality of Life [Time frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months]
  • Fecal Incontinence Severity Index (FISI) [Time frame: 6 Month, 9 Month, 12 Month, 24 Month, 36 Month]
  • Health Related Quality of Life [Time frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months]
  • Pain Score [Time frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months]
  • Rescue Analgesic and Therapeutic Antibiotic Use [Time frame: 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • The Colorectal Institute — Fort Myers
  • Hackensack University Medical Center — Hackensack
  • Weill Cornell Medicine — New York
  • Northwell Health — Staten Island
  • Maininle Health Lankenau — Bryn Mawr
  • Geisinger — Danville

Identifiers

NCT: NCT07021742 · SP002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗