Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT06632418
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a single tract perianal fistula not amenable to fistulotomy as determined by the supervising surgeon
* Fistula must currently have a draining seton in place
* Aged \>21 years old
* Willing and able to provide informed consent and to comply with study protocol and follow-up
* Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
* Medical conditions that would, in the opinion of the investigator or treating provider, compromise the safety of the individual with study participation and/or the ability of the individual to follow study protocol
* Genito-urinary fistulization, including rectovaginal (i.e., fistulas that transverse the vaginal canal)
* Presence of an ileal anal pouch
* Any major surgery of the gastrointestinal tract (including one or more segments of the colon or terminal ileum) within 3 months prior to randomization; presence of stoma is not exclusionary
* Prior surgical procedure (i.e., Ligation of Intersphincteric Fistula Tract or Endorectal Advancement Flap) for the target fistula or a perianal procedure that resulted in a large soft tissue defect within 6 months prior to screening visit
* One or more of the following fistula types or anatomic presentations: horseshoe fistulas, fistulas that do not have an opening inside the anal canal or low rectum, blind ending sinus tracts (no external opening), branching fistulas (a previously performed conversion of a branching fistula tract to a single tract is not exclusionary), \>1 internal opening, moderate or severe proctitis, severe rectal mucosal fibrosis surrounding the internal opening preventing the securing of the fistula plug disk, any anatomical limitation to successfully securing the fistula plug disk.
* Known allergic reactions to porcine collagen or yeast-derived products
* Currently enrolled in a drug or device trial or within 30 days of last investigational drug or device administration at baseline visit where investigational treatment (drug or device) was placed in or near the fistula tract or may potentially interact with study treatment
* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
* Active infection at the application site
* The presence of malignant neoplasms at the application site
* Prior radiation therapy at the application site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06632418
Study Brief:
Protocol Section:
NCT06632418