N/A
N=740
I-scan for Adenoma Detection
Colorectal Adenomatous Polyps
Bottom Line
View on ClinicalTrials.gov: NCT02811419 ↗Enrolled (actual)
740
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected — 208; 171 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- i-scan (Device); standard high-definition white light (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected |
208; 171 | — |
| SECONDARY Number of Participants With Conventional Adenoma Detected |
174; 140 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02811419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.