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COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?

NCT04723758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2032

Last updated 2023-11-28

No results posted yet for this study

Summary

COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it.

Conditions

  • Colonic Polyp
  • Colorectal Polyp
  • Colorectal Adenoma
  • Colorectal Adenomatous Polyp
  • Colorectal SSA
  • Sessile Serrated Adenoma
  • Sessile Colonic Polyp

Interventions

DEVICE

GI Genius-assisted diagnostic colonoscopy

Participants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure.

DIAGNOSTIC_TEST

Diagnostic Colonoscopy

Diagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure.

Sponsors & Collaborators

  • North Wales Organisation for Randomised Trials in Health

    collaborator OTHER

  • Newcastle University

    collaborator OTHER

  • Medtronic

    collaborator INDUSTRY

  • South Tyneside and Sunderland NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Colin J Rees, MBBS · Newcastle University, South Tyneside and Sunderland NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2023-04-06
Completion
2023-04-20

Countries

  • United Kingdom

Study Locations

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Entities

Companies

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 NCT04723758 on ClinicalTrials.gov