Computer Aided Detection of Polyps During Colonoscopy Procedures

Colo-rectal Cancer Clinical Trial

Official title:

Computer Aided Detection of Polyps During Colonoscopy Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195646
• Other study ID #: EV-CS-001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2021
• Source: EndoVigilant Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 28, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colo-rectal Cancer
• Colonic Polyps
• Polyp of Colon
• Polyps

Intervention

Device:
• EndoVigilant CAD Software
The CAD software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the CAD software is installed on a computer system unit that utilizes an an operating system.

Locations

Country	Name	City	State
United States	Greenbelt Endoscopy Center	Greenbelt	Maryland
United States	VA Palo Alto Healthcare	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
EndoVigilant Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenomas Per Colonoscopy	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.	1 hour