MedTrace Logo

Accuracy of Real Time Characterization in Artificial Intelligence-assisted Colonoscopy

NCT05754229 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2024-02-13

No results posted yet for this study

Summary

The goal of this substudy is to investigate the accuracy of a computer-aided polyp characterization (CADx) system. The main question\[s\] it aims to answer are:

• How high is the specificity of the AI system when characterizing colorectal polyps

Participants will receive a standard colonoscopy, assisted by the artificial intelligence (AI) assisted system GI Genius.

Researchers will compare the AI system´s characterization with the histopathology to see how accurate the system is.

Conditions

Interventions

DEVICE

AI-assisted colonoscopy

The patients 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
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-03-03
Completion
2025-09-30

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 NCT05754229 on ClinicalTrials.gov