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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Colonic Polyp, Colonoscopy, Artificial Intelligence, Colonic Adenoma, Colonic Neoplasms

Intervention / Treatment
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* Other: Genius® System-assisted Colonoscopy
* Other: Standard Colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |