NCT04723758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,032

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

January 5, 2021

Last Update Submit

November 21, 2023

Conditions

Colonic PolypColorectal PolypColorectal AdenomaColorectal Adenomatous PolypColorectal SSASessile Serrated AdenomaSessile Colonic Polyp

Keywords

Diagnostic ColonoscopyArtificial IntelligenceComputer-Aided Detection

Outcome Measures

Primary Outcomes (1)

  • Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP)

    The number of adenomas identified during each colonoscopy will be summed and divided by the total number of colonoscopies performed. MAP is usually expressed as a number to one decimal place (e.g. 1.2).

    The number of adenomas detected in each procedure will be counted at 14 days post-procedure

Secondary Outcomes (30)

  • Proportion of participants in whom at least one adenoma is detected at colonoscopy, as indicated by the Adenoma Detection Rate (ADR)

    The presence or absence of any adenomas will be determined at 14 days post-procedure

  • Number of adenomas per participant detected at colonoscopy in the 'screening' participant population, as indicated by MAP for that participant population.

    The number of adenomas detected will be counted at 14 days post-procedure

  • Number of adenomas per participant detected at colonoscopy in the 'symptomatic' participant population, as indicated by MAP for that participant population

    The number of adenomas detected will be counted at 14 days post-procedure

  • Proportion of participants in the 'screening' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population

    The presence or absence of any adenomas will be determined at 14 days post-procedure

  • Proportion of participants in the 'symptomatic' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population

    The presence or absence of any adenomas will be determined at 14 days post-procedure

  • +25 more secondary outcomes

Other Outcomes (3)

  • Cost-effectiveness of GGC versus SC

    Costs associated with each participant's procedure and care will be calculated at time of 14-day review

  • Number of adenomas per participant detected at colonoscopy, amongst colonoscopists not participating in the study, as indicated by MAP

    At time of 14-day review

  • Proportion of participants in whom at least one adenoma is detected at colonoscopy, by colonoscopists not participating in the study, as indicated by ADR

    At time of 14-day review

Study Arms (2)

GI Genius-assisted colonoscopy (GGC)

EXPERIMENTAL

In the GGC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure, except that at some point prior to commencing withdrawal of the colonoscope, a member of the endoscopy staff will turn on the GI Genius machine. This will remain operational from the time it is switched on until the end of the procedure.

Device: GI Genius-assisted diagnostic colonoscopy

Standard Colonoscopy (SC)

ACTIVE COMPARATOR

In the SC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure.

Diagnostic Test: Diagnostic Colonoscopy

Interventions

GI Genius-assisted diagnostic colonoscopyDEVICE

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.

GI Genius-assisted colonoscopy (GGC)
Diagnostic ColonoscopyDIAGNOSTIC_TEST

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

Standard Colonoscopy (SC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent
  • Patients attending for colonoscopy
  • Through standard National Health Service (NHS) care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, positive FIT (faecal immunohistochemical test) based on symptoms, those referred on basis of family history, abnormal cross- sectional imaging, polyp surveillance or post CRC surveillance)
  • Through Bowel Cancer Screening Programme (FIT positive, surveillance)
  • Colonoscopy to be performed by colonoscopist trained to perform GGC as part of the study

You may not qualify if:

  • Absolute contraindications to colonoscopy
  • Patients lacking capacity to give informed consent
  • Confirmed or expected pregnancy
  • Established or suspected large bowel obstruction or pseudo-obstruction
  • Known presence of colorectal cancer or polyposis syndromes
  • Known colonic strictures (meaning that the colonoscopy maybe incomplete)
  • Known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  • Inflammatory Bowel Disease (IBD) surveillance procedures
  • Patients who are on clopidogrel, warfarin, or other antiplatelet agents or anticoagulants who have not stopped this for the procedure (as polyps cannot be removed and thus histology cannot be confirmed)
  • Patients who are attending for a planned therapeutic procedure or assessment of a known lesion
  • Patients referred with polyps identified on Bowel Scope procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

North Tees and Hartlepool NHS Foundation Trust

Hartlepool, County Durham, TS24 9AH, United Kingdom

Location

University Hospitals of Morecambe Bay NHS Foundation Trust

Kendal, Cumbria, LA9 7RG, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

North Shields, North Tyneside, NE29 8NH, United Kingdom

Location

Kettering General Hospital NHS Foundation Trust

Kettering, Northamptonshire, NN16 8UZ, United Kingdom

Location

University Hospitals Sussex NHS Foundation Trust

Worthing, Sussex, BN11 2DH, United Kingdom

Location

South Tees Hospitals NHS Foundation Trust

Middlesbrough, Teesside, United Kingdom

Location

The Newcastle-upon-Tyne Hospitals NHS Trust

Newcastle upon Tyne, Tyne & Wear, NE7 7DN, United Kingdom

Location

South Tyneside and Sunderland NHS Foundation Trust

Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

Location

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Bolton NHS Foundation Trust

Bolton, BL4 0JR, United Kingdom

Location

Related Publications (2)

  • Seager A, Sharp L, Neilson LJ, Brand A, Hampton JS, Lee TJW, Evans R, Vale L, Whelpton J, Bestwick N, Rees CJ; COLO-DETECT trial team. Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):911-923. doi: 10.1016/S2468-1253(24)00161-4. Epub 2024 Aug 14.

    PMID: 39153491DERIVED

  • Seager A, Sharp L, Hampton JS, Neilson LJ, Lee TJW, Brand A, Evans R, Vale L, Whelpton J, Rees CJ. Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius artificial intelligence endoscopy module with standard colonoscopy. Colorectal Dis. 2022 Oct;24(10):1227-1237. doi: 10.1111/codi.16219. Epub 2022 Jun 28.

    PMID: 35680613DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Colin J Rees, MBBS

    Newcastle University, South Tyneside and Sunderland NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patient and colonoscopist (care provider) cannot be blinded to the allocation. The investigator and statistician will remain blinded to the allocation until analysis has been conducted.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 26, 2021

Study Start

March 29, 2021

Primary Completion

April 6, 2023

Study Completion

April 20, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(10)