Computer Aided Detection of Polyps During Colonoscopy Procedures

NCT04195646 | Completed FDA Device

• 1 other identifier: EV-CS-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Colo-rectal Cancer; Polyp of Colon; Adenomatous Polyps

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EndoVigilant CAD Software assisted Colonoscopy Procedure

EXPERIMENTAL

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

Interventions

EndoVigilant CAD Software DEVICE

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.

EndoVigilant CAD Software assisted Colonoscopy Procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• EndoVigilant Inc: lead

Study Sites (2)

VA Palo Alto Healthcare

Palo Alto, California, 94304, United States

Location

Greenbelt Endoscopy Center

Greenbelt, Maryland, 20706, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps; Adenomatous Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: October 1, 2019
• Primary Completion: February 15, 2020
• Study Completion: February 28, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)