Computer-aided Detection Device in Standard Colonoscopy

Status Recruiting

Clinical Trial Summary

The aim of this study is to evaluate the clinical benefit and safety of using an AI device in colonoscopy procedures with the indication of screening or surveillance.

Clinical Trial Description

Colorectal cancer is the second most common cause of cancer related mortality in the U.S., and affecting 150,000 people annually. Colonoscopy is the gold standard for the screening and detection of colorectal polyps and cancers. Screening for colorectal cancer has been shown to be effective in reducing both incidence and mortality. The capability of colonoscopy as an effective screening tool is based on the accurate detection and removal of precancerous polyps. However, it has been documented in several tandem colonoscopy studies that up to 28% of colorectal polyps are missed. Detection and identification of adenomatous polyps is provider dependent, as evidenced by the large variability in adenoma detection rates between providers.

Additionally, procedural factors, such as poor bowel preparation, and histomorphological qualities, such as those of serrated polyps, can impact a clinician's ability to detect and characterize polyps. Iterative Scopes has developed a computer aided detection (CADe) or AI model that can identify colorectal polyps in real-time during colonoscopy. The Iterative Scopes AI model analyzes video digital images taken during endoscopy and then directs the gastroenterologist's attention to areas of interest on the colon wall.

The purpose of this study is to evaluate the health benefits and safety in using the AI device during screening and surveillance colonoscopy. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of AI device, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04149184
Study type	Interventional
Source	University of Minnesota
Contact	Aasma Shaukat, MD, MPH
Phone	612-208-1570
Email	shaukat@umn.edu
Status	Recruiting
Phase	N/A
Start date	October 1, 2019
Completion date	December 31, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.