The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

May 10, 2018 updated by: Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso
This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:

  1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
  2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
  3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
  4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center at El Paso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.

Exclusion Criteria:

  1. Patients younger than 18 yrs old or older than 80 yrs.
  2. Patients with a prior history of colonic surgeries
  3. Patient with Crohns colitis or ulcerative colitis.
  4. Patient with prior history of colon cancer
  5. Patient with poor bowel preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cap Assisted Colonoscopy
Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.
Device: Cap Assisted Colonoscopy
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Active Comparator: Conventional colonoscopy
A conventional colonoscopy does not use a Cap in order to perform the procedure
Device: Conventional colonoscopy
Regular colonoscopy as per standard clinical guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
Time Frame: 1 year
1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center, El Paso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2012

Primary Completion (Actual)

February 2, 2015

Study Completion (Actual)

February 2, 2015

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Actual)

June 7, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E12050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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