Clinique Paris-Bercy
Charenton-le-Pont, 94220, France
NCT Number: NCT04440865
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Charenton-le-Pont, 94220, France
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:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Genius® Intelligence System is used to assist Colonoscopy
Standard Colonoscopy without Genius® Intelligence System is performed
Time frame: 1 day
percentage of colonoscopy with one or more adenoma of the colon
Time frame: 1 day
percentage of colonoscopy with one or more advanced neoplasia of the colon
Time frame: 1 day
percentage of colonoscopy with one or more serrated polyp of the colon
Time frame: 1 day
percentage of colonoscopy with one or more polyp of the colon
Time frame: 1 day
Withdrawal time (in seconds): time of exploration from the caecum to the anal verge
Time frame: 1 day
Boston scale (0 to 9)
Time frame: 1 day
Time to reach caecum from the beginning of the procedure (in seconds)
Time frame: 1 day
Caecal intubation rate (complete colonoscopy)
Time frame: 7 days after procedure
Perforation rates (%)
Time frame: 7 days after procedure
Bleeding rates (%)
Clinique Paris-Bercy
Other
Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial
Acronym: COLO-GENIUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06792292
Artificial Intelligence, Colonic Adenoma
Auderghem, Brussels Capital, Belgium
View Trial DetailsNCT03901651
Colonic Adenoma, Colonic Diseases
Guayaquil, Guayas, Ecuador
View Trial DetailsNCT03139942
Colon Hyperplastic Polyp, Colonic Adenocarcinoma
London, United Kingdom
View Trial DetailsNCT04906343
Colonic Cancer, Colonic Diseases
Móstoles, Madrid, Spain
View Trial Details