Recruiting

BioHealx DeviceBioHealx® Anal Fistula Device Post Market Surveillance Study

Sponsor:

Signum Surgical USA Inc.

Code:

NCT07021742

Conditions

Fistula-in-ano

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BioHealx

Study Details

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

Study ID

NCT07021742

Start date

Jun 14, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

BioHealx

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

Interventions

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 measure

Successful Closure Repair [ Time Frame: 12 Months ]
Non-Recurrence Incidence [ Time Frame: 24 and 36 Months ]

Central Contacts and Locations

Central contacts

Katy Feeny

610-860-6577 kjclinconsulting@gmail.com

Locations

The Colorectal Institute

Recruiting

Fort Myers, Florida, United States, 33912

Principal Investigator:

J Neale, MD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

S Taubes

551-996-4371 susan.taubes@hmhn.org

Principal Investigator:

S Lee-Kong, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

KM Muktasid

646-962-2270 kmm4010@med.cornell.edu

Principal Investigator:

Lea Lowenfeld, MD, FACS, FASCRS

Northwell Health

Recruiting

Staten Island, New York, United States, 10305

Contacts

S Belotte

718-226-6398 sbelotte@northwell.edu

Principal Investigator:

Poppy Addison, MD

Maininle Health Lankenau

Recruiting

Bryn Mawr, Pennsylvania, United States, 19010

Contacts

Mainline Health Lankenau

484-476-1000 HandforthK@mlhs.org

Principal Investigator:

P Pearson, MD

Geisinger

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

K Rebuck

570-271-6856 krebuck@geisinger.edu

Principal Investigator:

Christopher Buzas, DO

More Information

Sponsor

Signum Surgical USA Inc.

Last update posted

Jun 3, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Signum Surgical USA Inc. on 2026-06-03.