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Computer Aided Detection of Polyps in Colonoscopy

Primary Purpose

Colorectal Polyp

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Aided Detection device
Sponsored by
Iterative Scopes, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Polyp focused on measuring Screening Colonoscopy, Artificial Intelligence, Computer Aided Detection, Adenoma Detection Rate, Adenomas per Colonoscopy, Surveillance Colonoscopy, Colorectal Cancer, Software as a Medical Device

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts General Hospital
  • Boston Medical Center
  • Mount Auburn Hospital
  • MNGI Digestive Health
  • Concord Endoscopy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental

Arm Description

Routine Colonoscopy

Routine Colonoscopy with the use of Skout

Outcomes

Primary Outcome Measures

Adenomas per colonoscopy
The total number of adenomas detected divided by the total number of colonoscopies.
Positive predictive value
The total number of adenomas and serrated lesions detected divided by the total number of extractions.

Secondary Outcome Measures

Adenoma detection rate
The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected.
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.
Colorectal cancer surveillance interval
The mean recommended timeframe for follow up colonoscopy.

Full Information

First Posted
February 10, 2021
Last Updated
November 29, 2021
Sponsor
Iterative Scopes, Inc
Collaborators
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04754347
Brief Title
Computer Aided Detection of Polyps in Colonoscopy
Official Title
Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iterative Scopes, Inc
Collaborators
University of Minnesota

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1472 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine Colonoscopy
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Routine Colonoscopy with the use of Skout
Intervention Type
Device
Intervention Name(s)
Computer Aided Detection device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adenomas per colonoscopy
Description
The total number of adenomas detected divided by the total number of colonoscopies.
Time Frame
At the end of the procedure, 1 day
Title
Positive predictive value
Description
The total number of adenomas and serrated lesions detected divided by the total number of extractions.
Time Frame
At the end of the procedure, 1 day
Secondary Outcome Measure Information:
Title
Adenoma detection rate
Description
The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected.
Time Frame
At the end of the procedure, 1 day
Title
Sessile serrated lesions detected
Description
The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps.
Time Frame
At the end of the procedure, 1 day
Title
Colorectal cancer surveillance interval
Description
The mean recommended timeframe for follow up colonoscopy.
Time Frame
At the end of the procedure, 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aasma Shaukat, MD, MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Mount Auburn Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
MNGI Digestive Health
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Concord Endoscopy Center
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35643173
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.
Results Reference
derived

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Computer Aided Detection of Polyps in Colonoscopy

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