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Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy

NCT03160859 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2023-12-12

Study results available
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Summary

This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). 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 during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.

Conditions

  • Unsedated Colonoscopy
  • Water Exchange Colonoscopy
  • Cap
  • Colonoscopy Pain

Interventions

OTHER

Control

Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.

DEVICE

Study method

Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.

Sponsors & Collaborators

  • VA Northern California Health Care System

    collaborator FED

  • VA Palo Alto Health Care System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-08
Primary Completion
2022-10-28
Completion
2022-10-28
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03160859 on ClinicalTrials.gov