NCT01952418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,805

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 14, 2017

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

September 19, 2013

Results QC Date

March 3, 2017

Last Update Submit

April 21, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adenoma Detection Rate (All Indications)

    Number of patients with adenoma detected

    within 2 weeks (range of 1 day-14 days) of the endoscopy

  • Adenoma Detection Rate (Screening Exams Only)

    Number of patients with adenoma detected

    within 2 weeks (range of 1 day-14 days) of the endoscopy

Secondary Outcomes (2)

  • Polyp Detection Rate (All Indications)

    recorded during endoscopy (immediate)

  • Polyp Detection Rate (Screening Exams Only)

    recorded during endoscopy (immediate)

Study Arms (2)

Standard monitor (24")

NO INTERVENTION

Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").

Large monitor (32")

ACTIVE COMPARATOR

Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").

Device: Monitor size

Interventions

Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32") video monitor or the standard (24") video monitor.

Large monitor (32")

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Jovani M, Campbell EJ, Hur C, Joshi AD, Nishioka NS. Effect of video monitor size on polyp detection: a prospective, randomized, controlled trial. Gastrointest Endosc. 2019 Aug;90(2):254-258.e2. doi: 10.1016/j.gie.2019.03.1172. Epub 2019 Apr 12.

Results Point of Contact

Title
Norman Nishioka, MD
Organization
Massachusetts General Hospital

Study Officials

  • Norman S Nishioka, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
15 endoscopists and 1805 patients on which procedures were performed were randomly assigned to each room.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 30, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

May 30, 2017

Results First Posted

April 14, 2017

Record last verified: 2017-04

Locations