Computer Aided Detection of Polyps During Colonoscopy Procedures

• Sponsor: EndoVigilant Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04195646
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Arm: 1
• Actual Duration (Months): 4.9
• Patients Per Site: 150
• Patients Per Site Per Month: 30.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colo-rectal Cancer; Polyp of Colon; Adenomatous Polyps	Device: EndoVigilant CAD Software	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Computer Aided Detection of Polyps During Colonoscopy Procedures
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Feb 15, 2020
• Actual Study Completion Date: Feb 28, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: EndoVigilant CAD Software assisted Colonoscopy Procedure 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.

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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Healthcare	Palo Alto	California	United States	94304
2	Greenbelt Endoscopy Center	Greenbelt	Maryland	United States	20706

Sponsors and Collaborators

• EndoVigilant Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EndoVigilant Inc
• ClinicalTrials.gov Identifier: NCT04195646
• Other Study ID Numbers: EV-CS-001
• First Posted: Dec 12, 2019
• Last Update Posted: Sep 2, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Adenomatous Polyps; Polyps; Colonic Polyps

Study Results

No Results Posted as of Sep 2, 2021