Trial Details
Not RecruitingBasic Information
| Clinical ID | c3180 |
|---|---|
| Identifier | NL-OMON37258 |
| Trial Title | Assessment of the Photopill Capsule Treatment for safety and feasibility in healthy volunteers, a phase 1 trial - Photopill treatment, a phase 1 trial |
| Trial URL | Visit Original Page |
Study Information
| Study Results | Yes |
|---|---|
| Conditions | darmen van gezonde proefpersonen, uiteindelijk doel is darmonstekingen te behandelen Inflammatory Bowel Disease Ulcerative Colitis |
| 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 till 10 cm. 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 3cm colon mucosa is covered. 1 Treatmensession will constist of 5 sequential treatments with a 10 minutes break in between. In total 2 treatment sessions will take place within 14 days. At day 0 and day 14 a sigmoidoscopy 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 | 2012-10-11 |