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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT01480635
Eligibility Criteria:
Inclusion Criteria:
* Subject is \>/= 18 years
* Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
* Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum \>45 min), adverse reaction to sedation requiring termination of colonoscopy
Exclusion Criteria:
* Subject has dysphagia or any swallowing disorder
* Subject has severe congestive heart failure or renal insufficiency
* Subject with high risk for capsule retention
* Subject has a cardiac pacemakers or other implanted electromedical devices
* Subject has any allergy or other contraindication to the medications used in the study
* Subject is expected to undergo MRI examination 7 days after capsule ingestion Subject has any condition, which precludes compliance with study and/or device instructions.
* Women who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
* Subject suffers from life threatening conditions
* Subject currently participating in another clinical study
* Colonoscopy had been performed by a physician who has experience of \<1000 complete colonoscopies
* Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
* Time interval between incomplete colonoscopy and capsule endoscopy \>30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01480635
Study Brief:
Protocol Section:
NCT01480635