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Effect of Video Monitor Size on Adenoma Detection Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01952418
Recruitment Status : Completed
First Posted : September 30, 2013
Results First Posted : April 14, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Norman Nishioka, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Adenoma Device: Monitor size Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1805 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: 15 endoscopists and 1805 patients on which procedures were performed were randomly assigned to each room.
Primary Purpose: Diagnostic
Official Title: Effect of Video Monitor Size on Adenoma Detection Rate
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Polyp Detection Rate (All Indications) [ Time Frame: recorded during endoscopy (immediate) ]
    Number of patients with polyps detected

  2. Polyp Detection Rate (Screening Exams Only) [ Time Frame: recorded during endoscopy (immediate) ]
    Number of patients with polyps detected



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952418


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Norman S Nishioka, MD Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Norman Nishioka, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01952418    
Other Study ID Numbers: 2013p001462
First Posted: September 30, 2013    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms