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AI Colorectal Polyp Detection

Primary Purpose

Polyp Colorectal, Adenoma Colon

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EW10-EC02 (Endoscopy Support Program)
Sponsored by
Fujifilm Medical Systems USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polyp Colorectal

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
  • Patients aged 45 or older
  • Patients who can provide an informed consent

Exclusion Criteria:

  • Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
  • Patients who are pregnant or are planning pregnancy during study period
  • Patients who are not able to or refuse to give informed consent

Sites / Locations

  • Keck Medicine University of Southern California
  • Largo Medical Center (HCA)
  • Brigham and Women's Hospital
  • GI Associates
  • Saint Luke's Hospital of Kansas City
  • Kansas City VA Medical Center
  • New York University/Manhattan Endoscopy
  • Columbia University Medical Center
  • Virginia Mason Medical Center
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CAC Group

CC Group

Arm Description

Inspection with computer assisted colonoscopy.

Inspection with conventional colonoscopy

Outcomes

Primary Outcome Measures

Adenoma per colonoscopy (APC)
Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies

Secondary Outcome Measures

Positive predictive value (PPV)
Total number of histologically confirmed adenomas and carcinomas detected during the colonoscopy, divided by the total number of excisions in the colonoscopy
Adenoma detection rate (ADR)
proportion of patients with at least one histologically confirmed adenoma or carcinoma detected in the colonoscopy

Full Information

First Posted
July 19, 2021
Last Updated
September 15, 2023
Sponsor
Fujifilm Medical Systems USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04979962
Brief Title
AI Colorectal Polyp Detection
Official Title
Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujifilm Medical Systems USA, Inc.

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
No

5. Study Description

Brief Summary
This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp Colorectal, Adenoma Colon

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Patients will be randomized 1:1, inspection with computer assisted colonoscopy: inspection with conventional colonoscopy.
Allocation
Randomized
Enrollment
1162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAC Group
Arm Type
Experimental
Arm Description
Inspection with computer assisted colonoscopy.
Arm Title
CC Group
Arm Type
No Intervention
Arm Description
Inspection with conventional colonoscopy
Intervention Type
Device
Intervention Name(s)
EW10-EC02 (Endoscopy Support Program)
Intervention Description
EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.
Primary Outcome Measure Information:
Title
Adenoma per colonoscopy (APC)
Description
Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies
Time Frame
1 day/procedure
Secondary Outcome Measure Information:
Title
Positive predictive value (PPV)
Description
Total number of histologically confirmed adenomas and carcinomas detected during the colonoscopy, divided by the total number of excisions in the colonoscopy
Time Frame
1 day/procedure
Title
Adenoma detection rate (ADR)
Description
proportion of patients with at least one histologically confirmed adenoma or carcinoma detected in the colonoscopy
Time Frame
1 day/procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater) Patients aged 45 or older Patients who can provide an informed consent Exclusion Criteria: Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease Patients who are pregnant or are planning pregnancy during study period Patients who are not able to or refuse to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prateek Sharma, MD
Organizational Affiliation
Kansas City VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck Medicine University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Largo Medical Center (HCA)
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Brigham and Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
GI Associates
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
New York University/Manhattan Endoscopy
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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AI Colorectal Polyp Detection

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