BioHealx® Anal Fistula Device Post Market Surveillance Study

Signum Surgical USA Inc.

Status

Not yet enrolling

Conditions

Fistula-in-ano

Treatments

Device: BioHealx

Study type

Observational

Funder types

Industry

Identifiers

NCT07021742

SP002

Details and patient eligibility

About

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).

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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