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I-scan for Adenoma Detection

Primary Purpose

Colorectal Adenomatous Polyps

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
i-scan
standard high-definition white light
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Adenomatous Polyps

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California San Francisco Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

i-scan

Standard high-definition white light

Arm Description

Inspection with i-scan surface enhancement

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Conventional Adenoma Detected

Full Information

First Posted
June 21, 2016
Last Updated
April 17, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02811419
Brief Title
I-scan for Adenoma Detection
Official Title
I-scan Versus Standard High-Definition White Light for the Detection of Adenomatous Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenomatous Polyps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
740 (Actual)

8. Arms, Groups, and Interventions

Arm Title
i-scan
Arm Type
Active Comparator
Arm Description
Inspection with i-scan surface enhancement
Arm Title
Standard high-definition white light
Arm Type
Active Comparator
Arm Description
Inspection with standard high-definition white light (usual care)
Intervention Type
Device
Intervention Name(s)
i-scan
Other Intervention Name(s)
colonoscopy
Intervention Description
examination will be performed with i-scan digital enhancement
Intervention Type
Device
Intervention Name(s)
standard high-definition white light
Other Intervention Name(s)
colonoscopy
Intervention Description
examination will be performed with high-definition white light
Primary Outcome Measure Information:
Title
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With Conventional Adenoma Detected
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey K Lee, MD
Organizational Affiliation
Primary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29935326
Citation
Kidambi TD, Terdiman JP, El-Nachef N, Singh A, Kattah MG, Lee JK. Effect of I-scan Electronic Chromoendoscopy on Detection of Adenomas During Colonoscopy. Clin Gastroenterol Hepatol. 2019 Mar;17(4):701-708.e1. doi: 10.1016/j.cgh.2018.06.024. Epub 2018 Jun 20.
Results Reference
derived

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I-scan for Adenoma Detection

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