I-scan for Adenoma Detection

Colorectal Adenomatous Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811419
• Other study ID #: P072016
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: April 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: January 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colorectal Adenomatous Polyps
• Polyps

Intervention

Device:
• i-scan
examination will be performed with i-scan digital enhancement
• standard high-definition white light
examination will be performed with high-definition white light

Locations

Country	Name	City	State
United States	University of California San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected		12 months
Secondary	Number of Participants With Conventional Adenoma Detected		12 months