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 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
NCT ID:
NCT02428595
Eligibility Criteria:
Abbreviated Inclusion Criteria:
* History of Fecal Incontinence (FI) for at least 6 months
* Subject willing and able to give written informed consent to participate in the study
* Subject can read, write and communicate fluently in English
* Subject willing and able to comply with visit schedule
* Subject is able to physically manage the insertion and removal of the Insert
Abbreviated Exclusion Criteria:
* Vaginal childbirth within the last 18 months
* Currently pregnant or planning pregnancy during the study period
* Acute infections or genito-urinary injuries that would impact comfortable device use
* Current treatment for Fecal Incontinence other than medical management
* Removal or diversion of any portion of the bowel
* Recent urogenital or colorectal surgeries
* Chronic abdominal pain in absence of diarrhea
* Chronic (\>6 mos) rectal, anal or pelvic pain
* Chronic watery diarrhea, unmanageable by drugs or diet
* Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis
* Rectal prolapse (mucosal or full thickness)
* Grade III or IV hemorrhoids
* Pelvic organ prolapse beyond the plane of the hymen
* Concurrent use of intra-vaginal pessary or other device
* Anal or pelvic malignancy within last 5 years
* History of pelvic irradiation for cancer
* Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT02428595
Study Brief:
Protocol Section:
NCT02428595