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Real-Time Feedback (RTFB) to Improve Colonoscopy

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AI program for colonoscopy
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

- Any endoscopist willing to parcipate and performing routine colonscopy

Exclusion Criteria:

- No exclusion criteria

Sites / Locations

  • Johns Hopkins UniversityRecruiting
  • University of MinnesotaRecruiting
  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Testing of degree of mucosal inspection

Testing of clearing of fecal debris

Arm Description

AI provides real-time feedback related to circumferential views during endoscope removal

AI provides real-time feedback related to removal of remaining fecal debris

Outcomes

Primary Outcome Measures

Adenoma Detection Rate
Percent change in ADR

Secondary Outcome Measures

Full Information

First Posted
January 4, 2022
Last Updated
February 2, 2022
Sponsor
University of Minnesota
Collaborators
University of Washington, Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05241210
Brief Title
Real-Time Feedback (RTFB) to Improve Colonoscopy
Official Title
Real-Time Feedback (RTFB) to Improve Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
University of Washington, Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To test whether real-time feedback will improve quality of endoscopic examination.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Multiple successive arms testing new feedback options
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Testing of degree of mucosal inspection
Arm Type
Experimental
Arm Description
AI provides real-time feedback related to circumferential views during endoscope removal
Arm Title
Testing of clearing of fecal debris
Arm Type
Experimental
Arm Description
AI provides real-time feedback related to removal of remaining fecal debris
Intervention Type
Device
Intervention Name(s)
AI program for colonoscopy
Intervention Description
Provides real-time feedback on the endoscopist moniter during colonoscopy.
Primary Outcome Measure Information:
Title
Adenoma Detection Rate
Description
Percent change in ADR
Time Frame
5 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Any endoscopist willing to parcipate and performing routine colonscopy Exclusion Criteria: - No exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Villar-Mead
Phone
612-301-3981
Email
villa679@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piet de Groen, MD
Organizational Affiliation
UMN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Villar-Mead
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Real-Time Feedback (RTFB) to Improve Colonoscopy

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