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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT02208258
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool.
* Non-ambulatory, hospitalized patients.
* History of passage of at least 1 stool in 24 hours.
Exclusion Criteria:
* Patients with suspected or confirmed rectal mucosal impairment or pathology.
* Patients with have undergone descending colon or rectal surgery within the preceding six months.
* Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination.
* Patients suspected to have impacted stool or is suffering from constipation.
* Patients with confirmed pregnancy or suspected to be pregnant.
* Patients that have planned MRI examination over the duration of the study.
* Patients who have suffered recent cardiac arrest within the preceding 3 months.
* Patients enrolled in another clinical study or clinical trial.
* Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid , Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02208258
Study Brief:
Protocol Section:
NCT02208258