Clinical trial NCT04440865: Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy (COLO-GENIUS)
Official title: Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Colonoscopy
Artificial Intelligence
Colonic Adenoma
Colonic Neoplasms
Lead sponsor: Clinique Paris-Bercy
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma Detection Rate (ADR)
timeFrame: 1 day
Secondary outcomes:
measure: Advanced Neoplasia Detection Rate (ANDR)
timeFrame: 1 day
measure: Proximal Serrated Polyp Detection Rate (PSPDR)
timeFrame: 1 day
measure: Polyp Detection Rate (PDR)
timeFrame: 1 day
measure: The factors influencing the Adenoma Detection Rate (ADR)
timeFrame: 1 day
measure: The factors influencing the Adenoma Detection Rate (ADR)
timeFrame: 1 day
measure: Time to reach caecum (sec)
timeFrame: 1 day
measure: Caecal intubation rate (%)
timeFrame: 1 day
measure: Morbidity: perforation rate (%)
timeFrame: 7 days after procedure
measure: Morbidity: bleeding rate (%)
timeFrame: 7 days after procedure
Other outcomes:
Locations:
city: Charenton-le-Pont
country: France
facility: Clinique Paris-Bercy
Study officials:
affiliation: Clinique Paris-Bercy
name: David Karsenti, MD
role: STUDY_DIRECTOR
References: