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

Colonoscopy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440865
• Other study ID #: COLO-GENIUS
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: April 2022
• Source: Clinique Paris-Bercy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2100
• Est. completion date: April 20, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Artificial Intelligence
• Colonic Adenoma
• Colonic Neoplasms
• Colonic Polyp
• Colonic Polyps
• Colonoscopy

Intervention

Other:
• Genius® System-assisted Colonoscopy
Genius® Intelligence System is used to assist Colonoscopy
• Standard Colonoscopy
Standard Colonoscopy without Genius® Intelligence System is performed

Locations

Country	Name	City	State
France	Clinique Paris-Bercy	Charenton-le-Pont

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Paris-Bercy

Country where clinical trial is conducted

France, 

Outcome

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