NCT05935124

Brief Summary

A randomized controlled crossover study to determine if narrow band imaging or white light endoscopy is superior in detecting right colonic polyps in average risk subjects undergoing screening colonoscopy

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

9.8 years

First QC Date

June 28, 2023

Last Update Submit

March 25, 2025

Conditions

Adenoma Colon

Outcome Measures

Primary Outcomes (1)

  • Rate of right sided polyp detection with WLE and B-NBI

    1 day

Secondary Outcomes (1)

  • Rate of the detection of SSPs in the right colon with WLE and B-NBI

    1 day

Study Arms (2)

First withdrawal - White light endoscopy

OTHER

white light (WLE) high definition colonoscope (Olympus 190 series) first and then B-NBI

Diagnostic Test: WLE first, then B-NBI

First withdrawal - Bright Narrow Band Imagin

OTHER

B-NBI first and then WLE with the same colonoscope.

Diagnostic Test: WLE first, then B-NBI

Interventions

WLE first, then B-NBIDIAGNOSTIC_TEST
First withdrawal - Bright Narrow Band ImaginFirst withdrawal - White light endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic subjects undergoing screening colonoscopy
  • age \> 50.
  • average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of FAP or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma, no colonoscopy in past 5 years and, ability to provide a written consent to trial participation

You may not qualify if:

  • unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

Central Study Contacts

Michael Bourke, MBBS

CONTACT

8890555

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: randomized crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endoscopy

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 7, 2023

Study Start

August 1, 2015

Primary Completion

May 1, 2025

Study Completion

November 1, 2025

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)