Computer Aided Detection of Polyps in Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Polyp
• Interventions: Device: Computer Aided Detection device

• Registration Number: NCT04754347
• Lead Sponsor: Iterative Scopes, Inc

Brief Summary

The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-22
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1472

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Computer Aided Detection device	Routine Colonoscopy with the use of Skout

Primary Outcome Measures

Name	Time	Method
Adenomas per colonoscopy	At the end of the procedure, 1 day	The total number of adenomas detected divided by the total number of colonoscopies.
Positive predictive value	At the end of the procedure, 1 day	The total number of adenomas and serrated lesions detected divided by the total number of extractions.

Secondary Outcome Measures

Name	Time	Method
Adenoma detection rate	At the end of the procedure, 1 day	The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected.
Colorectal cancer surveillance interval	At the end of the procedure, 1 day	The mean recommended timeframe for follow up colonoscopy.
Sessile serrated lesions detected	At the end of the procedure, 1 day	The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps.

Trial Locations

Locations (5)

Concord Endoscopy Center; 🇺🇸 Concord, New Hampshire, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Mount Auburn Hospital; 🇺🇸 Cambridge, Massachusetts, United States

MNGI Digestive Health; 🇺🇸 Plymouth, Minnesota, United States