Clinical trial NCT07021742: BioHealx® Anal Fistula Device Post Market Surveillance Study
Official title: BioHealx® Anal Fistula Device Post Market Surveillance Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fistula-in-ano
Lead sponsor: Signum Surgical USA Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for treatment of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition.

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).


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

Primary outcomes:
measure: Successful Closure Repair
timeFrame: 12 Months
measure: Non-Recurrence Incidence
timeFrame: 24 and 36 Months
Secondary outcomes:
measure: Fecal Incontinence Quality of Life
timeFrame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
measure: Fecal Incontinence Severity Index (FISI)
timeFrame: 6 Month, 9 Month, 12 Month, 24 Month, 36 Month
measure: Health Related Quality of Life
timeFrame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
measure: Pain Score
timeFrame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
measure: Rescue Analgesic and Therapeutic Antibiotic Use
timeFrame: 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Other outcomes:
measure: Device and Procedure Related Adverse Events
timeFrame: 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
measure: Adverse Event Comparison
timeFrame: 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
measure: Occurrence of Fecal Incontinence
timeFrame: Baseline, 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
measure: Rescue Analgesic and Therapeutic Antibiotic Comparison
timeFrame: 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Locations:
Study officials:
References: