I-Scan Vs High Definition White Light (Main Study)

Summary

The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.

Primary Outcome:

Adenoma Detection Rate (ADR - No. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.

Secondary Outcomes:

* Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.
* Adenoma Detection Rate (ADR) in the right colon during the "Second look", irrespective of imaging modality.
* Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were found(regardless of the histological type) divided by the total no. of colonoscopies performed in the Same time period) for each arm of the study in Right colon and throughout the entire colon.
* Mean number of adenomas per procedure for each arm of the study in right colon and throughout the entire colon.
* Mean number of polyps per procedure for each arm of the study in right colon and throughout the entire colon.
* Number of neoplastic lesions for each arm of the study in the right colon and throughout the entire colon and number of neoplastic lesions missed on 1st pass of right colon.
* Proportion of patients with diminutive lesions (\< 5 mm) in each arm of the study
* Proportion of patients with Flat lesions (height \< 1/2 diameter) in each arm of the study
* Proportion of patients with Sessile Serrated Adenoma in each arm of the study
* Proportion of patients with invasive cancer in each arm of the study
* Presence or absence of learning effect while using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.

Conditions

• Colorectal Cancer

Interventions

DEVICE

HD Colon

High Definition White Light

DEVICE

I-scan 1

I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.

DEVICE

I-Scan 2

I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE)and Tone Enhancement(TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities. TE provides a uniform color image and is intended for detailed inspection of distinct lesions.

Sponsors & Collaborators

• University of Calgary

  lead OTHER

Principal Investigators

• Dr.Robert Hilsden, MD · Faculty of Medicine, University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2014-11-30

Completion

2014-11-30

Countries

• Canada

Study Locations