Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial
| Registry | NCT04440865, acronym COLO-GENIUS |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 2100 (Actual) |
| Sponsor | Clinique Paris-Bercy (Other) |
| Conditions | Colonic Polyp, Colonoscopy, Artificial Intelligence, Colonic Adenoma, Colonic Neoplasms |
| Interventions | Genius® System-assisted Colonoscopy, Standard Colonoscopy (Other) |
| Dates | start 2021-02-01, primary completion 2022-04-01, completion 2022-04-20, first posted 2020-06-22, last updated 2022-05-06 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Colonic Polyp All trials for Colonoscopy All trials of Genius® System-assisted Colonoscopy All trials of Standard Colonoscopy
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).
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1- Standard colonoscopy | Active comparator | Other: Standard Colonoscopy | Standard colonoscopy is performed |
| Arm 2- Colonoscopy assisted by Genius | Active comparator | Other: Genius® System-assisted Colonoscopy | Colonoscopy assisted by Genius artificial intelligence system is performed |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Clinique Paris-Bercy | Charenton-le-Pont | France |