Computer Aided Detection of Polyps in Colonoscopy
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|ClinicalTrials.gov Identifier: NCT04754347|
Recruitment Status : Completed
First Posted : February 15, 2021
Last Update Posted : December 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Polyp||Device: Computer Aided Detection device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1472 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy|
|Actual Study Start Date :||January 22, 2021|
|Actual Primary Completion Date :||October 31, 2021|
|Actual Study Completion Date :||October 31, 2021|
No Intervention: Control
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.
- Adenomas per colonoscopy [ Time Frame: At the end of the procedure, 1 day ]The total number of adenomas detected divided by the total number of colonoscopies.
- Positive predictive value [ Time Frame: At the end of the procedure, 1 day ]The total number of adenomas and serrated lesions detected divided by the total number of extractions.
- Adenoma detection rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At the end of the procedure, 1 day ]The mean recommended timeframe for follow up colonoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754347
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Mount Auburn Hospital|
|Cambridge, Massachusetts, United States, 02138|
|United States, Minnesota|
|MNGI Digestive Health|
|Plymouth, Minnesota, United States, 55446|
|United States, New Hampshire|
|Concord Endoscopy Center|
|Concord, New Hampshire, United States, 03301|
|Principal Investigator:||Aasma Shaukat, MD, MPH||University of Minnesota|