Effect of Video Monitor Size on Adenoma Detection Rate

April 21, 2017 updated by: Norman Nishioka, MD, Massachusetts General Hospital
The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26") used at this facility while the other room will have a larger video monitor (NDS 32"). The ADR achieved by each physician in each room will be compared.

Study Type

Interventional

Enrollment (Actual)

1805

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit
  • Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit

Exclusion Criteria:

  • Refusal to participate

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard monitor (24")
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
Active Comparator: Large monitor (32")
Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").
Device: Monitor size
Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32") video monitor or the standard (24") video monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Detection Rate (All Indications)
Time Frame: within 2 weeks (range of 1 day-14 days) of the endoscopy
Number of patients with adenoma detected
within 2 weeks (range of 1 day-14 days) of the endoscopy
Adenoma Detection Rate (Screening Exams Only)
Time Frame: within 2 weeks (range of 1 day-14 days) of the endoscopy
Number of patients with adenoma detected
within 2 weeks (range of 1 day-14 days) of the endoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp Detection Rate (All Indications)
Time Frame: recorded during endoscopy (immediate)
Number of patients with polyps detected
recorded during endoscopy (immediate)
Polyp Detection Rate (Screening Exams Only)
Time Frame: recorded during endoscopy (immediate)
Number of patients with polyps detected
recorded during endoscopy (immediate)

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Norman S Nishioka, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013p001462

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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