Fistula in AnoNCT07035925
Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
A study testing ECMT-100 in people with Fistula in Ano, run by ECM Therapeutics, Inc. at 2 sites in United States.
Trial summary
Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- ECMT-100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Nov 2025to 24 Apr 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects at least 18 years of age.
- Provide informed consent
- Non-pregnant females
- Clinical diagnosis of 1 high transsphincteric anorectal fistula, with 1 internal opening and 1-2 external openings, with a single seton in place.
- Seton placement for a minimum of four (4) weeks
- Willingness to participate in post-operative follow-up evaluations.
Who cannot join
- Inability to provide informed consent.
- Medical history of Crohn's disease/Ulcerative Colitis.
- Subjects with multiple fistula tracts (defined as >1 internal opening and/or >2 external openings), secondary tracts, horseshoe fistulas, J-pouch fistulas, superficial fistulas, ano/recto-vaginal fistulas or rectourethral fistulas.
- Previous fistulotomy/fistulectomy at the target treatment site (a history of these procedures at other locations is not exclusionary).
- Fistula of traumatic origin including obstetric.
- Evidence of ongoing local infection.
Show all 18Show fewer
- Evidence of active abscess at the time of treatment.
- Chronic disease such as congestive heart failure, liver disease, renal disease, insulin dependent diabetes (as determined by A1C reading from past 6-12 months), or any chronic illness that may interfere with participation in this study.
- Active and unstable disease state or infection anywhere in the body per Investigator's evaluation and determination.
- Autoimmune disease that is not stable.
- Subjects who are immunocompromised such as known human immunodeficiency virus (HIV) or currently receiving chemotherapy or radiation therapy.
- Ongoing use of antiplatelet drugs. Subjects may be included in the study if antiplatelet drugs have been stopped for 5 to 7 days prior to surgery.
- Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
- Pregnancy
- Previous history of radiation therapy in the area of the fistula.
- History of collagen disease.
- Known allergy to porcine products.
- Religious objection to use of porcine products.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Madison Duclos, 603-653-3607
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15237
Kim Sainiak, 412-647-1705, sainiakks@upmc.edu
About this study
Official title: Prospective Multi-Center, Single Arm, Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
Read the detailed description
ECMT-100 is a colloidal hydrogel derived from extracellular matrix (ECM), formulated to adhere to sub-epithelial soft tissue and allow for filling of anorectal fistulas to reinforce and promote fistula tract closure. ECMT-100 is a medical device and should be administered via catheter within the fistula tract following curettage of the tract, with draining setons used preoperatively.
ECMT-100 is a mucoadhesive hydrogel composed of ECM formulated to adhere to the gastrointestinal mucosa, fill the transsphincteric fistula tract, and promote tract closure by allowing for timely host tissue integration without fecal incontinence.
- Conditions
- Fistula in Ano
- Being tested
- ECMT-100
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMT-100Device
Colloidal hydrogel
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | ECMT-100
Subjects will be followed for 12 months following last treatment with ECMT-100.
Subjects are eligible for one repeat treatment as determined by the clinician/investigator at or prior to the 6-month visit. Receives: Device: ECMT-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of Adverse Events
Measured: 12 months from treatment
Secondary outcomes (3)
Percentage of Subjects in whom external openings of the fistula have closed
Physical exam to confirm closure and absence of discharge
Measured: 12 months from treatment
Changes in Fecal Incontinence
Wexner Score - Cleveland Clinic Fecal Incontinence Score; changes from baseline
Measured: 12 months from treatment
Changes in Quality of Life
Medical Outcomes Study Questionnaire Short Form 36; changes from baseline
Measured: 12 months from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start24 Nov 2025
- Primary completion24 Feb 2027 (estimated)
- Study completion24 Apr 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Multi-Center, Single Arm
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECM Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035925
- Sponsor's protocol ID
- ECMT-100-1
- Status last verified
- Dec 2025
- First submitted
- 13 May 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center, Single Arm, Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
- ClinicalTrials.gov ID
- NCT07035925
- Acronym / sponsor ID
- ECMT-100-1
- Conditions
- Fistula in Ano
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ECM Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 24 Apr 2028 (estimated)
- First posted
- 25 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.
Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
Detailed description
ECMT-100 is a colloidal hydrogel derived from extracellular matrix (ECM), formulated to adhere to sub-epithelial soft tissue and allow for filling of anorectal fistulas to reinforce and promote fistula tract closure. ECMT-100 is a medical device and should be administered via catheter within the fistula tract following curettage of the tract, with draining setons used preoperatively.
ECMT-100 is a mucoadhesive hydrogel composed of ECM formulated to adhere to the gastrointestinal mucosa, fill the transsphincteric fistula tract, and promote tract closure by allowing for timely host tissue integration without fecal incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Multi-Center, Single Arm
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: ECMT-100ECMT-100 Subjects will be followed for 12 months following last treatment with ECMT-100. Subjects are eligible for one repeat treatment as determined by the clinician/investigator at or prior to the 6-month visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects at least 18 years of age.
- Provide informed consent
- Non-pregnant females
- Clinical diagnosis of 1 high transsphincteric anorectal fistula, with 1 internal opening and 1-2 external openings, with a single seton in place.
- Seton placement for a minimum of four (4) weeks
Key exclusion criteria (18 listed)
- Inability to provide informed consent.
- Medical history of Crohn's disease/Ulcerative Colitis.
- Subjects with multiple fistula tracts (defined as >1 internal opening and/or >2 external openings), secondary tracts, horseshoe fistulas, J-pouch fistulas, superficial fistulas, ano/recto-vaginal fistulas or rectourethral fistulas.
- Previous fistulotomy/fistulectomy at the target treatment site (a history of these procedures at other locations is not exclusionary).
- Fistula of traumatic origin including obstetric.
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 |
|---|---|---|
| ECMT-100Colloidal hydrogel | Device | Treatment |
Primary outcome
Adverse Events
Time frame: 12 months from treatment
Number of Adverse Events
3 secondary outcomes
Percentage of Subjects in whom external openings of the fistula have closed
Time frame: 12 months from treatment
Changes in Fecal Incontinence
Time frame: 12 months from treatment
Changes in Quality of Life
Time frame: 12 months from treatment
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 31 Mar 2026.
Related trials for Fistula in Ano
Active, not recruitingPhase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Anal Fistula
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Active, not recruiting
A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Fistula-in-ano, Draining Wound
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECMT-100 in people with Fistula in Ano, run by ECM Therapeutics, Inc. at 2 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 6 inclusion and 18 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Julie Cramer (330-507-0801, julie@clinicalresearchstrategies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 12 months from treatment). 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 31 Mar 2026.