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Completed

NCT Number: NCT02811419

I-scan for Adenoma Detection

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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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco Medical Center

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

i-scan

Device

examination will be performed with i-scan digital enhancement

Other names: colonoscopy

standard high-definition white light

Device

examination will be performed with high-definition white light

Other names: colonoscopy

Primary outcomes

  1. Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected

    Time frame: 12 months

Secondary outcomes

  1. Number of Participants With Conventional Adenoma Detected

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jun 23, 2016
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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