Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04440865
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2020-06-18
Brief Title:
Impact of Artificial Intelligence Genius System-assisted Colonoscopy vs Standard Colonoscopy COLO-GENIUS
Sponsor:
Clinique Paris-Bercy
Organization:
Clinique Paris-Bercy
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLO-GENIUS
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None