NCT04440865

Brief Summary

This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy. The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

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

June 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

May 6, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

June 18, 2020

Last Update Submit

April 30, 2022

Conditions

Colonic PolypColonoscopyArtificial IntelligenceColonic AdenomaColonic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Adenoma Detection Rate (ADR)

    percentage of colonoscopy with one or more adenoma of the colon

    1 day

Secondary Outcomes (9)

  • Advanced Neoplasia Detection Rate (ANDR)

    1 day

  • Proximal Serrated Polyp Detection Rate (PSPDR)

    1 day

  • Polyp Detection Rate (PDR)

    1 day

  • The factors influencing the Adenoma Detection Rate (ADR)

    1 day

  • The factors influencing the Adenoma Detection Rate (ADR)

    1 day

  • +4 more secondary outcomes

Study Arms (2)

Arm 1- Standard colonoscopy

ACTIVE COMPARATOR

Standard colonoscopy is performed

Other: Standard Colonoscopy

Arm 2- Colonoscopy assisted by Genius

ACTIVE COMPARATOR

Colonoscopy assisted by Genius artificial intelligence system is performed

Other: Genius® System-assisted Colonoscopy

Interventions

Genius® System-assisted ColonoscopyOTHER

Genius® Intelligence System is used to assist Colonoscopy

Arm 2- Colonoscopy assisted by Genius
Standard ColonoscopyOTHER

Standard Colonoscopy without Genius® Intelligence System is performed

Arm 1- Standard colonoscopy

Eligibility Criteria

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

You may qualify if:

  • Patient scheduled for total colonoscopic exploration, during the period study
  • Patient over or equal to 18 years
  • ASA 1, ASA 2, ASA 3
  • No participation in another clinical study
  • Certificate of non opposition signed

You may not qualify if:

  • Patient under 18 years old
  • ASA 4, ASA 5
  • Pregnant woman
  • Patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, Platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
  • Patient referred for resection of a known polyp
  • Inflammatory bowel disease
  • Known colonic stenosis
  • Diverticulitis less than 6 weeks old
  • Patient unable to give consent or protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Paris-Bercy

Charenton-le-Pont, 94220, France

Location

Related Publications (1)

  • Karsenti D, Tharsis G, Perrot B, Cattan P, Percie du Sert A, Venezia F, Zrihen E, Gillet A, Lab JP, Tordjman G, Cavicchi M. Effect of real-time computer-aided detection of colorectal adenoma in routine colonoscopy (COLO-GENIUS): a single-centre randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):726-734. doi: 10.1016/S2468-1253(23)00104-8. Epub 2023 Jun 1.

    PMID: 37269872DERIVED

MeSH Terms

Conditions

Colonic PolypsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • David Karsenti, MD

    Clinique Paris-Bercy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 22, 2020

Study Start

February 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 20, 2022

Last Updated

May 6, 2022

Record last verified: 2022-04

Locations

FR(1)