BioHealx® Anal Fistula Device Post Market Surveillance Study

NCT07021742 | Recruiting DMC FDA Device

• 1 other identifier: SP002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Fistula-in-ano

Outcome Measures

Primary Outcomes (2)

• Successful Closure Repair

  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

  12 Months

• Non-Recurrence Incidence

  Non-recurrence incidence determined by continued closure of the external fistula opening.

  24 and 36 Months

Secondary Outcomes (5)

• Fecal Incontinence Quality of Life

  6 Months, 9 Months, 12 Months, 24 Months, 36 Months

• Fecal Incontinence Severity Index (FISI)

  6 Month, 9 Month, 12 Month, 24 Month, 36 Month

• Health Related Quality of Life

  6 Months, 9 Months, 12 Months, 24 Months, 36 Months

• Pain Score

  6 Months, 9 Months, 12 Months, 24 Months, 36 Months

• Rescue Analgesic and Therapeutic Antibiotic Use

  6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months

Other Outcomes (4)

• Device and Procedure Related Adverse Events

  6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months

• Adverse Event Comparison

  6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months

• Occurrence of Fecal Incontinence

  Baseline, 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months

Study Arms (1)

BioHealx

Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device.

Device: BioHealx

Interventions

BioHealx DEVICE

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.

BioHealx

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for treatment of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Signum Surgical USA Inc.: lead

Study Sites (5)

The Colorectal Institute

Fort Myers, Florida, 33912, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Northwell Health

Staten Island, New York, 10305, United States

RECRUITING

Maininle Health Lankenau

Bryn Mawr, Pennsylvania, 19010, United States

RECRUITING

Geisinger

Danville, Pennsylvania, 17822, United States

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Katy Feeny

CONTACT

610-860-6577; kjclinconsulting@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 15, 2025
• Study Start: June 14, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)