Computer Aided Detection of Polyps in Colonoscopy

Sponsor

Iterative Scopes, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT04754347

Collaborator

University of Minnesota (Other)

1,472

Enrollment

Locations

Arms

9.3

Actual Duration (Months)

294.4

Patients Per Site

31.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Polyp	Device: Computer Aided Detection device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1472 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy

Actual Study Start Date :

Jan 22, 2021

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Routine Colonoscopy
Experimental: Experimental Routine Colonoscopy with the use of Skout	Device: Computer Aided Detection device The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.

Arm

Intervention/Treatment

No Intervention: Control

Routine Colonoscopy

Experimental: Experimental

Routine Colonoscopy with the use of Skout

Device: Computer Aided Detection device

The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.

Outcome Measures

Primary Outcome Measures

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

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.
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.
Colorectal cancer surveillance interval [At the end of the procedure, 1 day]
The mean recommended timeframe for follow up colonoscopy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Participants will be eligible for this study if they are:

Undergoing colonoscopy with screening, surveillance, or diagnostic indications.
Undergoing a procedure by a participating endoscopist.
Have given informed consent.

Exclusion Criteria

Participants will not be eligible for this study if they:

Have a history of inflammatory bowel disease.
Have a history of familial adenomatous polyposis.
Are under the age of 40.
Have had a colonoscopy within the previous three (3) years.
Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test.
Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator).
Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Boston Medical Center	Boston	Massachusetts	United States	02118
3	Mount Auburn Hospital	Cambridge	Massachusetts	United States	02138
4	MNGI Digestive Health	Plymouth	Minnesota	United States	55446
5	Concord Endoscopy Center	Concord	New Hampshire	United States	03301