Computer Aided Detection of Polyps During Colonoscopy Procedures

Not Applicable

Completed

• Conditions: Colo-rectal Cancer; Polyp of Colon; Adenomatous Polyps
• Interventions: Device: EndoVigilant CAD Software

• Registration Number: NCT04195646
• Lead Sponsor: EndoVigilant Inc

Brief Summary

The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure.

Detailed Description

The details of the proposed study are as follows:

1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place. The video signal from the colonoscope will be fed into a computer running the EndoVigilant CAD software in addition to the standard video output to the procedure monitor. The EndoVigilant CAD software will display an annotated video on an additional monitor that includes both the colonoscopy picture and annotation by the software indicating the location of any polyps on the screen.

2. The endoscopist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the annotated video on the second monitor.

3. The endoscopist will primarily rely on the second monitor (augmented with annotation from EndoVigilant ColonCAD software) but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Primary Completion: 2020-02-15
• Study Completion: 2020-02-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patient presenting for routine colonoscopy for screening and/or surveillance purposes
• Ability to provide written, informed consent and understand the responsibilities of study participation

Exclusion Criteria

• Patients with diminished cognitive capacity
• Patients with inflammatory bowel disease, ulcerative colitis or Crohn's colitis
• Patients with incomplete colonoscopies (due to technical difficulties or poor bowel prep)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EndoVigilant CAD Software assisted Colonoscopy Procedure	EndoVigilant CAD Software	The gastroenterologist performing the colonoscopy procedure will be able to observe a standard colonoscopy video on the primary monitor and video augmented by EndoVigilant CAD software on the second monitor. The gastroenterologist will primarily rely on the second monitor but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.

Primary Outcome Measures

Name	Time	Method
Adenomas Per Colonoscopy	1 hour	Averaged Adenomas Per Colonoscopy (APC), to determine if the use of CAD software identifies more adenomas per colonoscopy. This will be generated for the entire study as well as each investigator. This prospectively collected data will be compared against APC for same number of past procedures performed without use of EndoVigilant CAD system, both at aggregate and physician level.

Trial Locations

Locations (2)

Greenbelt Endoscopy Center; 🇺🇸 Greenbelt, Maryland, United States

VA Palo Alto Healthcare; 🇺🇸 Palo Alto, California, United States