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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT03160859
Eligibility Criteria:
Inclusion Criteria:
* Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:
* diagnostic
* surveillance (follow up of polyps)
* screening (first-time) colonoscopy at participating sites
* choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)
Exclusion Criteria:
* decline to be randomized
* unable to give consent or respond to questionnaires
* history of colon surgery
* active inflammatory bowel disease
* lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)
* therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
* proctosigmoidoscopy
* bidirectional endoscopy
* inadequate consumption of bowel preparation
* known history of severe diverticulosis or diverticulitis
* history of abdominal surgery previously requiring sedation for colonoscopy
* current narcotic/anxiolytic medication use
* prior unsuccessful experience with unsedated colonoscopy
* emergent colonoscopy
* evidence of colonic obstruction based on pre-colonoscopy clinical evaluation
* current participation in other studies
* medical condition that could increase the risk associated with colonoscopy
* active cardiac
* or pulmonary disease
* or other serious disease
* medical condition that would preclude a benefit from colonoscopic screening
* cancer
* or any terminal illness
* prosthetic heart valve
* anticoagulant therapy
* nonmedical problems
* psychiatric disorders
* excessive use of alcohol
* need for special precautions in performing colonoscopy
* antibiotic prophylaxis
* request of on demand sedation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT03160859
Study Brief:
Protocol Section:
NCT03160859