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:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT06109961
Eligibility Criteria:
Inclusion Criteria:
* Adults (\>17 years old)
* Diagnosis of Crohn's disease based on standard endoscopic, radiologic and/or histologic criteria.
* One or more perianal fistula tract connecting the rectum and the perianal skin. Patients must have active fistula drainage and/or a recurrent perianal abscess within the past month.
* Failure or intolerance of conventional therapy (imuran, methotrexate, anti-TNF therapies, vedolizumab and/or ustekinumab). Failure is defined as persistent perianal drainage or recurrent abscesses after a minimum of 3 months of therapy.
* Standard or care treatment has been stable (dose and treatment interval) for at least 3 months.
* Able to provide written consent to participate
Exclusion Criteria:
* Fistulas not believed to be due to Crohn's disease (examples include, obstetrical complications, tuberculosis, anorectal cancer or diverticular fistula).
* Rectovaginal fistulas.
* Undrained perianal abscesses on pelvic MRI exams (abscesses will require successful drainage by an exam under anaesthesia with or without seton prior to study inclusion).
* Surgical procedure such as an advancement flap, fistula plug, fistula glue or ligation of intersphincteric fistula tract (LIFT) procedure within the past 6 months.
* Diverting ostomies or ileal pouch anal anastomosis.
* Current or planned pregnancy or lactation during the study treatment period.
* Contraindications to HBOT (claustrophobia, incompatible implanted medical device, and other conditions) based on the discretion of our HBOT clinicians.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT06109961
Study Brief:
Protocol Section:
NCT06109961