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Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.

NCT04909671 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2022-03-17

No results posted yet for this study

Summary

The purpose of this study is to assess if artificial intelligence aid colonoscopy colonoscopy is superior to conventional colonoscopy for the detection of adenomas during surveillance colonoscopy in patients with Lynch syndrome.

Conditions

Interventions

DEVICE

Gi Genius, Medtronic

GI geniusTM (Medtronic) is an artificial intelligence device designed and validated on a dataset of white-light endoscopy videos from high-quality randomized controlled trials for the detection of colorectal lesions during colonoscopy. Based on a deep learning system using convolutional neural networks, GI genius works in real-time side-to-side with the gastroenterologist during colonoscopy highlighting the presence of precancerous lesions with a visual marker (green box) in real time and designed to be integrated with the majority of colonoscopies.

OTHER

White light standart colonoscopy

High definition white light endoscopy will be used during the scope withdrawal

Sponsors & Collaborators

  • European Society of Gastrointestinal Endoscopy

    collaborator OTHER

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Spain

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 NCT04909671 on ClinicalTrials.gov