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A Clinical Study To Measure The Effect Of Use Of Artificial Intelligence (AI) Enabled Computer Aided Detection (CADe) Assistance Software In Detecting Colon Polyps During Standard Colonoscopy Procedures

NCT04555135 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 769

Last updated 2022-04-01

No results posted yet for this study

Summary

EndoVigilant software device augments existing colonoscopy procedure video in real-time by highlighting colon polyps and mucosal abnormalities. It is intended to assist gastroenterologists in detection of adenomas and serrated polyps. The device is an adjunctive tool and is not intended to replace physicians' decision making related to detection, diagnosis or treatment.

This study with an adaptive design measures the clinical benefit (increase in detection of adenomatous and serrated polyps) and increased risk (increased extraction of non-adenomas) during standard colonoscopy procedures when EndoVigilant software device is used.

Conditions

  • Colon Polyp
  • Colon Neoplasm
  • Colon Adenoma

Interventions

DEVICE

EndoVigilant Software

While using this device, colonoscopy will continue to be performed in the standard manner as is done without the use of this device. The video signal from the colonoscope will be fed into a computer running the EndoVigilant software in addition to the standard video output to the procedure monitor. The gastroenterologist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the augmented video on the second monitor. The gastroenterologist may rely on the second monitor (with augmented video generated from EndoVigilant software) for polyp detection, but the standard procedure monitor with the original feed will always be operational and available for maneuvers such as fast insertion, polypectomy etc.

Sponsors & Collaborators

  • EndoVigilant Inc

    lead INDUSTRY

Principal Investigators

  • Shai Friedland, MD · VA Palo Alto Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2021-09-24
Completion
2021-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04555135 on ClinicalTrials.gov