Colorectal CancerNCT05241210
Real-Time Feedback (RTFB) to Improve Colonoscopy
A study testing AI program for colonoscopy in people with Colorectal Cancer, run by University of Minnesota at 3 sites in United States.
Trial summary
To test whether real-time feedback will improve quality of endoscopic examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- AI program for colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,150 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Dec 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any endoscopist willing to parcipate and performing routine colonscopy
Who cannot join
- No exclusion criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21218
University of Minnesota
Minneapolis, Minnesota, 55455
University of Washington
Seattle, Washington, 98195
About this study
To test whether real-time feedback will improve quality of endoscopic examination.
- Conditions
- Colorectal Cancer
- Being tested
- AI program for colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI program for colonoscopyDevice
Provides real-time feedback on the endoscopist moniter during colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Testing of degree of mucosal inspection | Experimental | AI provides real-time feedback related to circumferential views during endoscope removal Receives: Device: AI program for colonoscopy |
| Testing of clearing of fecal debris | Experimental | AI provides real-time feedback related to removal of remaining fecal debris Receives: Device: AI program for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate
Percent change in ADR
Measured: 5 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start13 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: we are on hold and may restart depending on a manual followed by automated assessment of existing files
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multiple successive arms testing new feedback options
- Masking
- None (open label)
- Enrolment
- 4,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Piet de Groen, MD, Principal investigator, UMN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241210
- Sponsor's protocol ID
- GI-2019-28090
- Other IDs
- DK106130
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Feedback (RTFB) to Improve Colonoscopy
- ClinicalTrials.gov ID
- NCT05241210
- Acronym / sponsor ID
- GI-2019-28090
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: we are on hold and may restart depending on a manual followed by automated assessment of existing files
- Enrolment
- 4,150 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Washington, Johns Hopkins University
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test whether real-time feedback will improve quality of endoscopic examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple successive arms testing new feedback options
| Arm | Type | Receives |
|---|---|---|
| Testing of degree of mucosal inspection | Experimental | Device: AI program for colonoscopyAI provides real-time feedback related to circumferential views during endoscope removal |
| Testing of clearing of fecal debris | Experimental | Device: AI program for colonoscopyAI provides real-time feedback related to removal of remaining fecal debris |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any endoscopist willing to parcipate and performing routine colonscopy
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI program for colonoscopyProvides real-time feedback on the endoscopist moniter during colonoscopy. | Device | Testing of clearing of fecal debris, Testing of degree of mucosal inspection |
Primary outcome
Adenoma Detection Rate
Time frame: 5 months post procedure
Percent change in ADR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piet de Groen, MD principal investigator
UMN
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI program for colonoscopy in people with Colorectal Cancer, run by University of Minnesota at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (time frame: 5 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.