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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT04918758
Eligibility Criteria:
Inclusion criteria
* Age \>16 years old
* Pelvic radiotherapy completed \>6 months previously
* Endoscopically confirmed diagnosis of radiation proctopathy on lower GI endoscopy (sigmoidoscopy or colonoscopy) as characterised by the typical endoscopic appearances of superficial friable serpiginous telangiectasia, mucosal pallor and oedema
* Significant rectal bleeding (\>weekly passage of blood into toilet bowl +/- anaemia which is ongoing for at least 3 months)
* Full colonic evaluation (colonoscopy or CT colonogram) to exclude other causes for rectal bleeding
* Capable of providing informed consent to a participant information sheet written in English
Exclusion criteria
* Age \<16 years
* Unable to have full colonic evaluation to exclude other causes of rectal bleeding
* Other untreated cause for rectal bleeding
* Previous Purastat treatment for RP
* Previous Sucralfate treatment for RP
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04918758
Study Brief:
Protocol Section:
NCT04918758