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Computer Aided Detection of Polyps During Colonoscopy Procedures

Primary Purpose

Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyps

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EndoVigilant CAD Software
Sponsored by
EndoVigilant Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Colo-rectal Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • VA Palo Alto Healthcare
  • Greenbelt Endoscopy Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EndoVigilant CAD Software assisted Colonoscopy Procedure

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2019
Last Updated
September 1, 2021
Sponsor
EndoVigilant Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04195646
Brief Title
Computer Aided Detection of Polyps During Colonoscopy Procedures
Official Title
Computer Aided Detection of Polyps During Colonoscopy Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoVigilant Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
Detailed Description
The details of the proposed study are as follows: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyps

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EndoVigilant CAD Software assisted Colonoscopy Procedure
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
EndoVigilant CAD Software
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adenomas Per Colonoscopy
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
VA Palo Alto Healthcare
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Greenbelt Endoscopy Center
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Computer Aided Detection of Polyps During Colonoscopy Procedures

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