Real-Time Feedback (RTFB) to Improve Colonoscopy

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

Study Overview

• Status: Suspended
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: AI program for colonoscopy

• Study Type: Interventional
• Enrollment (Estimated): 4150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Any endoscopist willing to parcipate and performing routine colonscopy

Exclusion Criteria:

- No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Testing of degree of mucosal inspection; AI provides real-time feedback related to circumferential views during endoscope removal	Device: AI program for colonoscopy; Provides real-time feedback on the endoscopist moniter during 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; Provides real-time feedback on the endoscopist moniter during colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate	Percent change in ADR	5 months post procedure

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Johns Hopkins University; University of Washington
• Investigators: Principal Investigator: Piet de Groen, MD, UMN

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Colonoscopy
• Other Study ID Numbers: GI-2019-28090; DK106130 (Other Grant/Funding Number: University of Washington)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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