Fistula-in-ano
Conditions
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).
Interventions
DEVICEBioHealx
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.
Sponsors
Signum Surgical USA Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Closure Repair | 12 Months | 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 |
| Non-Recurrence Incidence | 24 and 36 Months | Non-recurrence incidence determined by continued closure of the external fistula opening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Incontinence Quality of Life | 6 Months, 9 Months, 12 Months, 24 Months, 36 Months | Fecal incontinence Quality of Life (FIQL) score at each follow-up visit (baseline visit and from 6-month and at subsequent follow-up visit) The FIQL score includes 29 items which form four scales: lifestyle, coping/behavior, depression/self-perception, and embarrassment. The FIQL scale range includes a range of response options across its items, from 1 to 4 for most items, 1 to 5 for one item, and 1 to 6 for another. Lower scores indicate lower quality of life. |
| Fecal Incontinence Severity Index (FISI) | 6 Month, 9 Month, 12 Month, 24 Month, 36 Month | Fecal Incontinence Severity Index (FISI) at each follow-up visit (baseline visit and from 6-month and at each subsequent follow-up visit). The Fecal Incontinence Severity Index (FISI) Scale typically ranges from 0 to a maximum value 61. Higher scores on the FISI scale indicate a worse outcome, reflecting greater severity of fecal incontinence symptoms. |
| Health Related Quality of Life | 6 Months, 9 Months, 12 Months, 24 Months, 36 Months | SF-36 Quality of life data will be collected (baseline visit and from 6-month and at each subsequent follow-up visit). Short Form 36 (SF-36) is a generic self-reported outcome measure that quantifies the quality of life in relation to health status. It is a 36-item valid and reliable evaluation with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The SF-36 also contains a single question called "health transition" that measures how respondents feel their over health status has changed over the course of a year. The scores range from 0-100 (the worst possible to the most possible) |
| Pain Score | 6 Months, 9 Months, 12 Months, 24 Months, 36 Months | Wong-Baker FACES Pain scores will be recorded at each follow-up visit (baseline visit and from 6-month and at each subsequent follow-up visit). The FACES Pain Scale ranges from 0 (no pain) to 10 (the worst pain). |
| Rescue Analgesic and Therapeutic Antibiotic Use | 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months | Occurrence of use of rescue analgesic and/or therapeutic antibiotics beyond post-operative Day 5 after the surgery and at each follow-up visit. |
Countries
United States
Contacts
CONTACTKaty Feeny
Outcome results
None listed