Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
Alimentiv Inc.
Summary
To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults (age ≥ 18 years) with a diagnosis of CD treated surgically with subtotal colectomy/proctocolectomy end ileostomy at least 12 months prior to the scheduled endoscopy procedure. 2. Planning to have an ileoscopy procedure scheduled as part of routine medical care. 3. Be proficient in the English language (ie, ability to read, write, speak, and understand English well enough to take part in the interview process without the aid of an interpreter). 4. Able and willing to participate fully in all aspects of this study. 5. Written informed consent must be obtained and d…
Locations (5)
- Mayo Clinic- RochesterRochester, Minnesota
- Washington University in St Louis School of MedicineSt Louis, Missouri
- Cleveland Clinic FoundationCleveland, Ohio
- McMaster University Medical CentreHamilton, Ontario
- LHSC - University CampusLondon, Ontario