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

Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Colonic Polyp; Artificial Intelligence; Colonic Neoplasms; Colonoscopy; Colonic Adenoma
• Intervention / Treatment: Other: Standard Colonoscopy; Other: Genius® System-assisted Colonoscopy

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 Type: Interventional
• Enrollment (Actual): 2100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Charenton-le-Pont, France, 94220
    • Clinique PARIS-BERCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1- Standard colonoscopy; Standard colonoscopy is performed	Other: Standard Colonoscopy; Standard Colonoscopy without Genius® Intelligence System is performed
Active Comparator: Arm 2- Colonoscopy assisted by Genius; Colonoscopy assisted by Genius artificial intelligence system is performed	Other: Genius® System-assisted Colonoscopy; Genius® Intelligence System is used to assist Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate (ADR)	percentage of colonoscopy with one or more adenoma of the colon	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinique Paris-Bercy
• Investigators: Study Director: David Karsenti, MD, Clinique PARIS-BERCY

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps; Colonic Neoplasms
• Other Study ID Numbers: COLO-GENIUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No