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Tests treatment safety and results for Fistula in Ano
Official title Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
ClinicalTrials.gov ID: NCT07035925
What this study is testing
- What it's testing
- Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female people 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
You likely can't join if
- Inability to provide informed consent.
- Medical history of Crohn's disease/Ulcerative Colitis.
- people with multiple fistula tracts (defined as \>1 internal opening and/or \>2 external openings), secondary tracts, horseshoe fistulas, J-pouch...
- 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.
See the full eligibility criteria
- Male and female people 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.
- Inability to provide informed consent.
- Medical history of Crohn's disease/Ulcerative Colitis.
- people 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...
- 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.
- 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...
- Active and unstable disease state or infection anywhere in the body per Investigator's evaluation and determination.
- Autoimmune disease that is not stable.
- people who are immunocompromised such as known human immunodeficiency virus (HIV) or currently receiving chemotherapy or radiation therapy.
- Ongoing use of antiplatelet drugs. people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon, New Hampshire, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon, New Hampshire, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.