Trial Details
Not RecruitingBasic Information
| Clinical ID | c3167 |
|---|---|
| Identifier | NL-OMON40086 |
| Trial Title | Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients with Ulcerative Proctitis, a Pilot Study __ - Photopill treatment for Ulcerative Proctitis |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Inflammatory Bowel Disease Ulcerative Colitis;10017969 |
| Interventions | After the rectum of the patient is cleaned with a Saline enema, the Photopill suppository capsule, mounted on a flexible rectal tube, will be inserted to the rectum to the pre-determined distance(based on sigmoidoscopy data). Finally the capsule will be activated. Every 2 minutes, the rectal tube will be pulled out 1 cm distal to the previous location, and will be held in the new location for 2 minutes. The process will be repeated until all the diseased area is covered. In total 10 treatment sessions will take place within the first 28 days. Follow-up will proceed untill day 42, when the last of the 4 sigmoidoscopies will be performed, |
Participant Information
| Sponsor | Photopill Medical Ltd |
|---|---|
| City | - |
| Country/Region | Netherlands |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | ADULT, ELDER, OLDER_ADULT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | Not Available |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |