I-scan for Adenoma Detection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-01-31

Brief Summary

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This study is a randomized controlled trial to determine whether i-scan can improve the detection of conventional adenomas and sessile serrated adenomas/polyps.

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Detailed Description

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This is a randomized controlled trial comparing the use of i-scan (digital surface and contrast enhancement of the mucosa) versus standard high-definition white light for the detection of conventional adenomas and sessile serrated adenomas/polyps. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as sessile serrated adenomas/polyps (SSA) are located primarily proximal to the splenic flexure. Sessile serrated adenomas/polyps share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Recent studies have shown that image enhanced endoscopy can highlight the appearance of these lesions. This study will test whether i-scan increases the detection of conventional adenomas and sessile serrated adenomas/polyps in a randomized controlled trial.

Conditions

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Colorectal Adenomatous Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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i-scan

Inspection with i-scan surface enhancement

Group Type ACTIVE_COMPARATOR

i-scan

Intervention Type DEVICE

examination will be performed with i-scan digital enhancement

Standard high-definition white light

Inspection with standard high-definition white light (usual care)

Group Type ACTIVE_COMPARATOR

standard high-definition white light

Intervention Type DEVICE

examination will be performed with high-definition white light

Interventions

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i-scan

examination will be performed with i-scan digital enhancement

Intervention Type DEVICE

standard high-definition white light

examination will be performed with high-definition white light

Intervention Type DEVICE

Other Intervention Names

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colonoscopy colonoscopy

Eligibility Criteria

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Inclusion Criteria

* Age 50-75
* Intact colon and rectum
* Willing to sign an informed consent form

Exclusion Criteria

* Subjects less than 50 years of age or greater than 75 years of age
* Subjects who are in the inpatient unit
* Subjects with diverticulitis,
* Subjects with inflammatory bowel disease
* Subjects with polyposis syndromes
* Subjects with previous surgical resection of any portion of the colon or rectum
* Subjects referred for endoscopic resection of previously diagnosed colorectal polyp

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes