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Adenoma Detection Rate in Artificial Intelligence-assisted Colonoscopy

NCT05740137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 795

Last updated 2025-03-06

No results posted yet for this study

Summary

The goal of this quasi randomized multicenter controlled clinical trial (RCT) is to investigate whether a combined real time computer-aided polyp detection (CADe) and computer-aided polyp characterization (CADx) system (GI Genius, Medtronic) can increase the adenoma detection rate (ADR) and reduce the performance variability among endoscopists.

Participants will be randomized (1:1) to either receive an AI-assisted colonoscopy (AIC) or a conventional colonoscopy (CC).

If there is a comparison group: Researchers will compare the AIC-group and the CC-group to see if AIC can increase the ADR significantly.

Conditions

Interventions

DEVICE

AI-assisted colonoscopy

The patients in the intervention group will receive an AI-assisted colonoscopy (AIC) using the computer-aided polyp detection and characterization (CADe and CADx) GI Genius (Medtronic).

Sponsors & Collaborators

  • Nykøbing Falster County Hospital

    collaborator OTHER

  • Naestved Hospital

    collaborator OTHER

  • Holbaek Sygehus

    collaborator OTHER

  • Slagelse Hospital

    collaborator OTHER

  • Ismail Gögenur

    lead OTHER

Principal Investigators

  • Ronja Lagström, MD · Zealand University Hospital, Køge

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-03-03
Completion
2023-03-03

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740137 on ClinicalTrials.gov