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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT03813251
Eligibility Criteria:
Inclusion Criteria:
1. Patient has signed the informed consent form and is willing to participate in the clinical study. Patient has the ability to self-manage insertion and removal of the device
2. Patient age is between 22 and 85 years old
3. Patient has history of fecal incontinence for at least 6 months
4. Patient has a minimum of four incontinence episodes during the 2-week baseline period
5. Patient colon surveillance complies with National Program/Guidelines for the Early Detection of Colorectal Cancer
6. Patient comprehends study meaning and is capable of carrying out study duties
7. If the candidate is currently prescribed medication per os or per rectum for bowel control, treatment has been administered for at least 4 weeks without a change in treatment regimen or dose, and the candidate agrees to continue the treatment without changes for the duration of the study
Exclusion Criteria:
1. Patient had spinal cord injury or other major neurological diagnosis
2. Patient has known life threatening disease such as cancer, immune deficiency state
3. Patient has significant cardiac arrhythmia\*
4. Patient has inflammatory bowel disease
5. Patient is on anti-coagulants and anti-platelets treatment, except Aspirin (low dose: 75-100 mg/day)
6. Patient has anorectal disease: perianal abscess, active fistula, fissure, hemorrhoids grade 3 or 4, Pruritus ani or rectal bleeding\*
7. Patient has a clinically significant abnormality as visualized by sigmoidoscopy at the first visit
8. Patient has pre-existing rectal pain or rectal bleeding
9. Patient suffers from chronic pelvic pain
10. Patient had rectal surgery in the past 6 months
11. Patient has rectocele or other pelvic organ prolapse requiring surgery\*
12. Patient has allergy to silicone or one of its components
13. Patient has significant medical condition which may interfere with study participation
14. Patient is currently participating in another clinical study.
15. Female patient is pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT03813251
Study Brief:
Protocol Section:
NCT03813251