We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Computer Aided Detection of Polyps in Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04754347
Recruitment Status : Completed
First Posted : February 15, 2021
Last Update Posted : December 1, 2021
Sponsor:
Collaborator:
University of Minnesota
Information provided by (Responsible Party):
Iterative Scopes, Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 22, 2021
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
Iterative Scopes, Inc
University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Aasma Shaukat, MD, MPH University of Minnesota
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Iterative Scopes, Inc
ClinicalTrials.gov Identifier: NCT04754347    
Other Study ID Numbers: Pro00047634
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Iterative Scopes, Inc:
Screening Colonoscopy
Artificial Intelligence
Computer Aided Detection
Adenoma Detection Rate
 Adenomas per Colonoscopy
Surveillance Colonoscopy
Colorectal Cancer
Software as a Medical Device
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyps
Pathological Conditions, Anatomical