Computer Aided Detection of Polyps in Colonoscopy

Colorectal Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754347
• Other study ID #: Pro00047634
• Status: Completed
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: Iterative Scopes, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1472
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Polyp
• Polyps

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mount Auburn Hospital	Cambridge	Massachusetts
United States	Concord Endoscopy Center	Concord	New Hampshire
United States	MNGI Digestive Health	Plymouth	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Iterative Scopes, Inc	University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenomas per colonoscopy	The total number of adenomas detected divided by the total number of colonoscopies.	At the end of the procedure, 1 day
Primary	Positive predictive value	The total number of adenomas and serrated lesions detected divided by the total number of extractions.	At the end of the procedure, 1 day
Secondary	Adenoma detection rate	The percentage of participants aged =50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected.	At the end of the procedure, 1 day
Secondary	Sessile serrated lesions detected	The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps.	At the end of the procedure, 1 day
Secondary	Colorectal cancer surveillance interval	The mean recommended timeframe for follow up colonoscopy.	At the end of the procedure, 1 day