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SuspendedNCT05241210Updated Dec 9, 2025

Real-Time Feedback (RTFB) to Improve Colonoscopy

An interventional study of AI program for colonoscopy in Colorectal Cancer, sponsored by University of Minnesota. Suspended at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

Why this study was suspended
we are on hold and may restart depending on a manual followed by automated assessment of existing files
Phase
Not applicable
Study type
Interventional
Enrollment
4,150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 4,150 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

- Any endoscopist willing to parcipate and performing routine colonscopy

Exclusion criteria

Exclusion Criteria:

- No exclusion criteria

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
4,150 participants (estimated)

Study arms

  • Experimental
    Testing of degree of mucosal inspection

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

    Device: AI program for colonoscopy

  • Experimental
    Testing of clearing of fecal debris

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

    Device: AI program for colonoscopy

Interventions

  • DeviceAI program for colonoscopy

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

06

What researchers measure

Primary outcomes

  1. Adenoma Detection Rate

    Percent change in ADR

    Time frame: 5 months post procedure

07

Study locations

3 sites
  • Johns Hopkins University
    Baltimore, Maryland 21218, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • University of Washington
    Seattle, Washington 98195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05241210
Lead sponsor
University of Minnesota
Collaborators
University of Washington, Johns Hopkins University
Responsible party
Sponsor
First posted
Feb 15, 2022
Start date
Dec 13, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 9, 2025

Study contacts

Piet de Groen, MD
principal investigator · UMN

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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