Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used

Status unconfirmed · Not applicable

Conditions studied: Colonoscopy, Polyp of Colon

In brief

This is a study to compare two different, but normally, used methods of colonoscopy in patients that require a routine or repeat colonoscopy. There will be three arms in this study: WE water control, water plus Cap-1, and water plus Cap-2. The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air inserted into the colon. The study method will use a new accessory, a cap that will fit onto the end of the colonoscope plus water during the procedure. This study will also confirm if using the cap method with water is a better way of detecting polyps in the colon and possibly cancer.

Key facts

Study ID

NCT03566615

Run by

VA Greater Los Angeles Healthcare System

People needed

1630

Starts

2018-07-01

Expected to finish

2023-01-31

Last updated by the study team

2022-10-06

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female 50-75 yrs of age.
• Positive screening for Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT).
• Subjects willing to undergo routine screening and surveillance colonoscopy.

You may not qualify if…

• Patients who decline to provide informed consent.
• Patients known to have colonic obstruction, inflammatory bowel disease, or active GI bleeding requiring interventions.
• Patients know to have prior history of severe diverticulitis/diverticulosis.

Where it is running

• Evergreen General Hospital — Taipei, Taiwan (enrolling)
• Veterans Affairs Palo Alto Healthcare System — Palo Alto, California, United States (enrolling)
• Xijing Hospital of Digestive Diseases — Xi'an, China (enrolling)
• Sacramento VAMC, VA Northern California Healthcare System — Mather, California, United States (enrolling)
• Dalin Tzu Chi General Hospital — Chiayi City, Taiwan (enrolling)
• Hualien Tzu Chi Hospital — Hualien City, Taiwan (enrolling)
• St. Barbara Hospital — Iglesias, Italy

Full record on ClinicalTrials.gov

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