Fistula-in-anoNCT07021742
BioHealx® Anal Fistula Device Post Market Surveillance Study
An observational study of Fistula-in-ano, run by Signum Surgical USA Inc. at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fistula-in-ano
- What is being tested?
- BioHealx
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Jun 2025to Dec 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for treatment of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Maininle Health Lankenau
Bryn Mawr, Pennsylvania, 19010
Mainline Health Lankenau, 484-476-1000, HandforthK@mlhs.org
P Pearson, MD
- Recruiting
Geisinger
Danville, Pennsylvania, 17822
K Rebuck, 570-271-6856, krebuck@geisinger.edu
Christopher Buzas, DO
- Recruiting
The Colorectal Institute
Fort Myers, Florida, 33912
J Neale, MD
J Neale, MD
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
S Taubes, 551-996-4371, susan.taubes@hmhn.org
S Lee-Kong, MD
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
KM Muktasid, 646-962-2270, kmm4010@med.cornell.edu
Lea Lowenfeld, MD, FACS, FASCRS
- Recruiting
Northwell Health
Staten Island, New York, 10305
S Belotte, 718-226-6398, sbelotte@northwell.edu
Poppy Addison, MD
About this study
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
- Being tested
- BioHealx
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioHealxDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BioHealx | Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device. Receives: Device: BioHealx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Non-Recurrence Incidence
Non-recurrence incidence determined by continued closure of the external fistula opening.
Measured: 24 and 36 Months
Secondary outcomes (5)
Fecal Incontinence Quality of Life
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.
Measured: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Fecal Incontinence Severity Index (FISI)
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.
Measured: 6 Month, 9 Month, 12 Month, 24 Month, 36 Month
Health Related Quality of Life
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)
Measured: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Pain Score
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).
Measured: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Rescue Analgesic and Therapeutic Antibiotic Use
Occurrence of use of rescue analgesic and/or therapeutic antibiotics beyond post-operative Day 5 after the surgery and at each follow-up visit.
Measured: 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start14 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula-in-anoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Signum Surgical USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021742
- Sponsor's protocol ID
- SP002
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioHealx® Anal Fistula Device Post Market Surveillance Study
- ClinicalTrials.gov ID
- NCT07021742
- Acronym / sponsor ID
- SP002
- Conditions
- Fistula-in-ano
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Signum Surgical USA Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioHealx | – | Device: BioHealxSubjects will have their anal fistula treated with the BioHealx Anal Fistula Device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for treatment of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioHealxSubjects 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. | Device | BioHealx |
Primary outcome
Successful Closure Repair
Time frame: 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
Time frame: 24 and 36 Months
Non-recurrence incidence determined by continued closure of the external fistula opening.
5 secondary outcomes
Fecal Incontinence Quality of Life
Time frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Fecal Incontinence Severity Index (FISI)
Time frame: 6 Month, 9 Month, 12 Month, 24 Month, 36 Month
Health Related Quality of Life
Time frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Pain Score
Time frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Rescue Analgesic and Therapeutic Antibiotic Use
Time frame: 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula-in-ano, run by Signum Surgical USA Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katy Feeny (610-860-6577, kjclinconsulting@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Closure Repair (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.