Computer Aided Detection of Polyps During Colonoscopy Procedures

EndoVigilant

Status: Completed

Conditions: Adenomatous Polyps; Colo-rectal Cancer; Polyp of Colon

Treatments: Device: EndoVigilant CAD Software

Study type: Interventional

Funder types: Industry

Identifiers

NCT04195646

EV-CS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

EndoVigilant CAD Software assisted Colonoscopy Procedure

Experimental group

Description:

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.

Treatment:

Device: EndoVigilant CAD Software