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

Clinique Paris-Bercy

Status

Completed

Conditions

Colonic Polyp

Colonic Neoplasms

Artificial Intelligence

Colonoscopy

Colonic Adenoma

Treatments

Other: Standard Colonoscopy

Other: Genius® System-assisted Colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04440865

COLO-GENIUS

Details and patient eligibility

About

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).

Full 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

Enrollment

2,100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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