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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01103492
Eligibility Criteria:
Inclusion Criteria:
1. History of pelvic irradiation. (Last radiation treatment must be greater than 6 months prior.)
2. Recurrent bloody stools.
3. Symptoms for \> 3 months.
4. No active infection or ulceration.
5. Diagnosis of radiation proctitis by endoscopic criteria.
6. Other sources of bloody stools, such as colon cancer, ulcerative colitis, or hemorrhoids, have been ruled out by prior colonoscopy.
7. Age ≥ 18 years old.
8. Subject is able to tolerate endoscopy and sedation.
9. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF).
Exclusion Criteria:
1. History of anal incontinence, rectal resection or anorectal malignancy.
2. Presence of anorectal fistulae or stenoses preventing passage of the endoscope and device.
3. Pregnancy and breastfeeding mothers
4. Subject is unable to provide informed consent for this study.
5. Pelvic irradiation within the last 6 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01103492
Study Brief:
Protocol Section:
NCT01103492