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

Not Applicable

Completed

• Conditions: Artificial Intelligence; Colonic Polyp; Colonic Neoplasms; Colonic Adenoma; Colonoscopy
• Interventions: Other: Standard Colonoscopy; Other: Genius® System-assisted Colonoscopy

• Registration Number: NCT04440865
• Lead Sponsor: Clinique Paris-Bercy

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

Study Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Study Start: 2021-02-01
• Status Verified: 2022-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-20
• Last Update Submitted: 2022-04-30
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1- Standard colonoscopy	Standard Colonoscopy	Standard colonoscopy is performed
Arm 2- Colonoscopy assisted by Genius	Genius® System-assisted Colonoscopy	Colonoscopy assisted by Genius artificial intelligence system is performed

Primary Outcome Measures

Name	Time	Method
Adenoma Detection Rate (ADR)	1 day	percentage of colonoscopy with one or more adenoma of the colon

Secondary Outcome Measures

Name	Time	Method
Advanced Neoplasia Detection Rate (ANDR)	1 day	percentage of colonoscopy with one or more advanced neoplasia of the colon
Proximal Serrated Polyp Detection Rate (PSPDR)	1 day	percentage of colonoscopy with one or more serrated polyp of the colon
Morbidity: perforation rate (%)	7 days after procedure	Perforation rates (%)
Morbidity: bleeding rate (%)	7 days after procedure	Bleeding rates (%)
Polyp Detection Rate (PDR)	1 day	percentage of colonoscopy with one or more polyp of the colon
The factors influencing the Adenoma Detection Rate (ADR)	1 day	Boston scale (0 to 9)
Time to reach caecum (sec)	1 day	Time to reach caecum from the beginning of the procedure (in seconds)
Caecal intubation rate (%)	1 day	Caecal intubation rate (complete colonoscopy)

Trial Locations

Locations (1)

Clinique Paris-Bercy; 🇫🇷 Charenton-le-Pont, France