Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas

Official title

Prospective Multi-Center, Single Arm, Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas

Overview

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.

Interventions

• Device ECMT-100
  Colloidal hydrogel

Primary outcome measures

• Adverse Events [Time frame: 12 months from treatment]

Secondary outcome measures (3)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Dartmouth Hitchcock Medical Center — Lebanon
• University of Pittsburgh Medical Center — Pittsburgh

Identifiers

NCT: NCT07035925 · ECMT-100-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗