NCT04440865

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,100 (actual)
• Sponsor: Clinique Paris-Bercy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Genius® System-assisted Colonoscopy	Genius® Intelligence System is used to assist Colonoscopy
OTHER	Standard Colonoscopy	Standard Colonoscopy without Genius® Intelligence System is performed

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-04-01
• Completion: 2022-04-20
• First posted: 2020-06-22
• Last updated: 2022-05-06

Locations

1 site across 1 country: France