Real-Time Feedback (RTFB) to Improve Colonoscopy

NCT ID: NCT05241210

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

4150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Multiple successive arms testing new feedback options
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Testing of degree of mucosal inspection

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

Group Type EXPERIMENTAL

AI program for colonoscopy

Intervention Type DEVICE

Provides real-time feedback on the endoscopist moniter during colonoscopy.

Testing of clearing of fecal debris

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

Group Type EXPERIMENTAL

AI program for colonoscopy

Intervention Type DEVICE

Provides real-time feedback on the endoscopist moniter during colonoscopy.

Interventions

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AI program for colonoscopy

Provides real-time feedback on the endoscopist moniter during colonoscopy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Any endoscopist willing to parcipate and performing routine colonscopy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Piet de Groen, MD

Role: PRINCIPAL_INVESTIGATOR

UMN

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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DK106130

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GI-2019-28090

Identifier Type: -

Identifier Source: org_study_id

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