NCT01737567

Brief Summary

Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

7.3 years

First QC Date

November 27, 2012

Last Update Submit

March 25, 2025

Conditions

Colonic Adenomas

Outcome Measures

Primary Outcomes (1)

  • Improvement in detection of colorectal adenomas.

    It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.

    One year

Secondary Outcomes (1)

  • Improvement of histological prediction

    One year

Study Arms (2)

Bright Narrow Band Imaging

EXPERIMENTAL

Use of B-NBI to detect colonic adenomas.

Other: Bright Narrow Band Imaging.

White Light Endoscopy

ACTIVE COMPARATOR

Use of White Light Endoscopy to detect colonic adenomas.

Other: White Light Endoscopy

Interventions

Bright Narrow Band Imaging.OTHER

Using Bright Narrow Band Imaging to detect colonic adenomas.

Bright Narrow Band Imaging
White Light EndoscopyOTHER

Use of White Light Endoscopy to detect colonic adenomas.

White Light Endoscopy

Eligibility Criteria

Age50 Years - 99 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 and, ability to provide a written consent to trial participation.

You may not qualify if:

  • personal history of inflammatory bowel disease, colon adenoma or cancer
  • family history of FAP or Familial nonpolyposis syndrome
  • first degree relatives having diagnosed to have colorectal carcinoma
  • no colonoscopy in past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

February 1, 2014

Primary Completion

June 1, 2021

Study Completion

June 1, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)