Clinical trial NCT04754347: Computer Aided Detection of Polyps in Colonoscopy
Official title: Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyp
Keywords: Screening Colonoscopy
Artificial Intelligence
Computer Aided Detection
Adenoma Detection Rate
Adenomas per Colonoscopy
Surveillance Colonoscopy
Colorectal Cancer
Software as a Medical Device
Lead sponsor: Iterative Scopes, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Minnesota
First posted: 2021-02-15
Enrollment: 1472
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adenomas per colonoscopy
timeFrame: At the end of the procedure, 1 day
measure: Positive predictive value
timeFrame: At the end of the procedure, 1 day
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: At the end of the procedure, 1 day
measure: Sessile serrated lesions detected
timeFrame: At the end of the procedure, 1 day
measure: Colorectal cancer surveillance interval
timeFrame: At the end of the procedure, 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Cambridge
country: United States
facility: Mount Auburn Hospital
state: Massachusetts
city: Plymouth
country: United States
facility: MNGI Digestive Health
state: Minnesota
city: Concord
country: United States
facility: Concord Endoscopy Center
state: New Hampshire
Study officials:
affiliation: University of Minnesota
name: Aasma Shaukat, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shaukat A, Lichtenstein DR, Somers SC, Chung DC, Perdue DG, Gopal M, Colucci DR, Phillips SA, Marka NA, Church TR, Brugge WR; SKOUT Registration Study Team. Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. 2022 Sep;163(3):732-741. doi: 10.1053/j.gastro.2022.05.028. Epub 2022 May 25.