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:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01613534
Eligibility Criteria:
Inclusion Criteria:
* radiotherapy due to pelvic tumors completed at least three months prior to enrollment
* presence of rectal bleeding
* radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy
* informed written consent to participate in the study
Exclusion Criteria:
* history of clinically significant rectal bleeding prior to radiotherapy
* conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream
* sucralfate treatment during the two weeks prior to enrollment
* renal insufficiency (creatinine level ≥2 mg/dl)
* concurrent chemotherapy
* concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because of drug interaction)
* concurrent therapy with oral anticoagulants
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01613534
Study Brief:
Protocol Section:
NCT01613534