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

NCT03566615 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1630

Last updated 2022-10-06

No results posted yet for this study

Summary

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.

Conditions

  • Colonoscopy
  • Polyp of Colon

Interventions

DEVICE

CAP-straight

This study is to detect any differences in the detection rate of adenomas using straight caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.

DEVICE

CAP-daisy

This study is to detect any differences in the detection rate of adenomas using daisy caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.

OTHER

water

using water instead of traditional air insufflation to help insertion

Sponsors & Collaborators

Principal Investigators

  • Felix W Leung, MD · VA Greater Los Angeles Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2022-12-31
Completion
2023-01-31

Countries

  • United States
  • China
  • Italy
  • Taiwan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03566615 on ClinicalTrials.gov