Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy (COLO-GENIUS)

NCT ID: NCT04440865

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-04-20

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).

Detailed Description

Any patient seen by gastroenterologists working in the endoscopy unit and meeting the inclusion criteria may be recruited.

The patient will be offered to participate in the study. The information form as well as the consent, will be given to the patient for a good understanding of the study and the investigator in charge of the patient gives all the additional explanations necessary for this good understanding (but of the study, the course, risks and benefits).

A period of reflection will be left to the patient or his family to make a free decision whether or not to participate in the study.

After the consent to participate will be signed by the gastroenterologist and the patient, the patient will be randomized. The use of the Genius® system will depend on the randomization that will be performed at the start of the colonoscopy.

This randomization will be done in the computer examination room using the randomization software.

The patient will therefore be randomized into 2 groups:

Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system

A comparison of the two groups standard colonoscopy vs colonoscopy assisted by Genius® system will be made as following:

A-Main criterion:

• Adenoma detection rate (ADR)

B-Secondary criteria:

Polyps detection rate (PDR) Proximal serrated polyps detection rate (PSPDR) Neoplasia detection rate (NDR) Mean number of polyps (MNP) Mean number of adenomas (MNA) Factors associated with ADR

Conditions

Colonic Polyp; Colonoscopy; Artificial Intelligence; Colonic Adenoma; Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1- Standard colonoscopy

Standard colonoscopy is performed

Group Type: ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type: OTHER

Standard Colonoscopy without Genius® Intelligence System is performed

Arm 2- Colonoscopy assisted by Genius

Colonoscopy assisted by Genius artificial intelligence system is performed

Group Type: ACTIVE_COMPARATOR

Genius® System-assisted Colonoscopy

Intervention Type: OTHER

Genius® Intelligence System is used to assist Colonoscopy

Interventions

Genius® System-assisted Colonoscopy

Genius® Intelligence System is used to assist Colonoscopy

Intervention Type: OTHER

Standard Colonoscopy

Standard Colonoscopy without Genius® Intelligence System is performed

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Opposition expressed for inclusion in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique Paris-Bercy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Karsenti, MD

Role: STUDY_DIRECTOR

Clinique Paris-Bercy

Locations

Clinique Paris-Bercy

Charenton-le-Pont, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37269872 (View on PubMed)

Other Identifiers

COLO-GENIUS

Identifier Type: -

Identifier Source: org_study_id