NCT05241210

Brief Summary

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

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
4,150

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
7mo left

Started Dec 2021

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

3 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Dec 2021Dec 2026

Study Start

First participant enrolled

December 13, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

5.1 years

First QC Date

January 4, 2022

Last Update Submit

December 2, 2025

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Adenoma Detection Rate

    Percent change in ADR

    5 months post procedure

Study Arms (2)

Testing of degree of mucosal inspection

EXPERIMENTAL

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

Device: AI program for colonoscopy

Testing of clearing of fecal debris

EXPERIMENTAL

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

Device: AI program for colonoscopy

Interventions

AI program for colonoscopyDEVICE

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

Testing of clearing of fecal debrisTesting of degree of mucosal inspection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Any endoscopist willing to parcipate and performing routine colonscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Piet de Groen, MD

    UMN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Multiple successive arms testing new feedback options
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 15, 2022

Study Start

December 13, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)