I-scan for Adenoma Detection
I-scan Versus Standard High-Definition White Light for the Detection of Adenomatous Polyps
1 other identifier
interventional
740
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedResults Posted
Study results publicly available
April 17, 2019
CompletedMay 1, 2019
April 1, 2019
11 months
June 21, 2016
March 25, 2019
April 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected
12 months
Secondary Outcomes (1)
Number of Participants With Conventional Adenoma Detected
12 months
Study Arms (2)
i-scan
ACTIVE COMPARATORInspection with i-scan surface enhancement
Standard high-definition white light
ACTIVE COMPARATORInspection with standard high-definition white light (usual care)
Interventions
examination will be performed with i-scan digital enhancement
examination will be performed with high-definition white light
Eligibility Criteria
You may qualify if:
- Age 50-75
- Intact colon and rectum
- Willing to sign an informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco Medical Center
San Francisco, California, 94115, United States
Related Publications (1)
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.
PMID: 29935326DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trilokesh Kidambi
- Organization
- University of California San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey K Lee, MD
Primary
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 23, 2016
Study Start
February 1, 2017
Primary Completion
December 31, 2017
Study Completion
January 31, 2018
Last Updated
May 1, 2019
Results First Posted
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share