I-scan for Adenoma Detection

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

Detailed Description
-----------------
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.

Official Title
-----------------
I-scan Versus Standard High-Definition White Light for the Detection of Adenomatous Polyps

Conditions
-----------------
Colorectal Adenomatous Polyps

Intervention / Treatment
-----------------
* Device: i-scan
* Device: standard high-definition white light


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: i-scan<br>Inspection with i-scan surface enhancement | Device: i-scan<br>* examination will be performed with i-scan digital enhancement<br>* Other names: colonoscopy;|
| Active Comparator: Standard high-definition white light<br>Inspection with standard high-definition white light (usual care) | Device: standard high-definition white light<br>* examination will be performed with high-definition white light<br>* Other names: colonoscopy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Conventional Adenoma Detected |  | 12 months |