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I-scan for Adenoma Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811419
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : April 17, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Colorectal Adenomatous Polyps Device: i-scan Device: standard high-definition white light Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: I-scan Versus Standard High-Definition White Light for the Detection of Adenomatous Polyps
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Active Comparator: i-scan
Inspection with i-scan surface enhancement
Device: i-scan
examination will be performed with i-scan digital enhancement
Other Name: colonoscopy

Active Comparator: Standard high-definition white light
Inspection with standard high-definition white light (usual care)
Device: standard high-definition white light
examination will be performed with high-definition white light
Other Name: colonoscopy




Primary Outcome Measures :
  1. Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of Participants With Conventional Adenoma Detected [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811419


Locations
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United States, California
University of California San Francisco Medical Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jeffrey K Lee, MD Primary
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02811419    
Other Study ID Numbers: P072016
First Posted: June 23, 2016    Key Record Dates
Results First Posted: April 17, 2019
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Adenomatous Polyps
Polyps
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms