Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy (COLO-GENIUS)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Artificial Intelligence
- Colonic Adenoma
- Colonic Neoplasms
- Colonic Polyp
- Colonoscopy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® systemMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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
Tracking Information
- NCT #
- NCT04440865
- Collaborators
- Not Provided
- Investigators
- Study Director: David Karsenti, MD Clinique Paris-Bercy