Clinical trial NCT05594576: Comparison of the ENDOCUFF VISION® Endoscopy Cap Coupled with GI GENIUS™ Artificial Intelligence Compared to Each Device Alone in Improving Colonic Adenoma Detection Rate During Colonoscopy
Official title: Comparison of the ENDOCUFF VISION® Endoscopy Cap Coupled with GI GENIUS™ Artificial Intelligence Compared to Each Device Alone in Improving Colonic Adenoma Detection Rate During Colonoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Adenoma
Intestinal Polyps
Keywords: colonoscopy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: University Hospital, Limoges
First posted: 2022-10-26
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Colorectal cancer is the 2nd most common cause of death by cancer. Screening is therefore essential, with a positive impact for prevention, and in the visualization and removal of colonic adenomas, pre-cancerous lesions of colorectal cancer.

The colonic adenoma detection rate (CADR), the gold standard for colonoscopy screening and screening studies, is the ratio of the number of colonoscopies with at least one histologically verified colonic adenoma to the total number of colonoscopies performed in a center. It varies between 25 and 45% depending on the center. There is a large inter-operator CADR variability, which has been linked to an increased incidence and excess mortality in colorectal cancers.

To improve this detection rate, several innovative techniques have been developed:

The endoscopic cap helps improve this detection rate: it is a 2cm tip with double row of plastic wings, fixed to the distal end of the colonoscope, which acts by unfolding the colonic haustrations allowing a better visualization of adenomas, and more particularly those of sessile morphology and sigmoidal location. Several multicenter studies have shown an improvement in the adenoma detection rate with this device compared to screening colonoscopy alone, with an adenoma detection rate optimization of 14%. Since then other devices, such as the Endocuff, have emerged with comparable efficacy. The Medtronic© GI GENIUS system integrates artificial intelligence (AI) to assist in the detection of polyps. It automatically identifies these precancerous lesions in real time.

The study investigators previously performed a retrospective pilot study (COLODETECT), comparing colonoscopy alone as a control group, against AI alone and against the combined cap + AI. This study showed encouraging results in terms of colonic adenoma detection rate (60% for the AI + cap group versus 37% for the AI alone group versus 33% for the colonoscopy alone group, p=0.037) However, it requires a higher level of evidence to be validated in practice. This prospective COLODETECT2 study estimated an a priori expected difference between A.I. - Cap and A.I. alone of about 15% CADR.

The GI GENIUS artificial intelligence system and the ENDOCUFF VISION endoscopic cap have separately proven their effectiveness in terms of colonic adenoma detection compared to colonoscopy alone. However, some limitations remain: existence of false positives (mucosal folds, residues), some morphological types still difficult to recognize (scalloped adenomas), non visualized colonic lesions.

This study therefore focuses on the possible complementarity of these 2 medical devices, in order to maximize the detection rate of colonic adenomas, and thus overcome the limitations of these two techniques by optimizing the visualization of these precancerous lesions, and consequently increasing the impact of colorectal cancer screening.

The study authors hypothesize that the combination of GI GENIUS™ AI coupled with the ENDOCUFF VISION® endoscopy cap provides a better colonic adenoma detection rate (CAD) during colonoscopy than either GI GENIUS™ AI alone or the ENDOCUFF VISION® cap alone.


Eligibility criteria: Inclusion Criteria:

* Need to perform colorectal cancer screening colonoscopy:

  * Primary Screening: Fecal Immunological Test positive;
  * Secondary screening: personal or family history of polyps, personal or family history of colorectal cancer, rectorrhagia-like symptomatology.
* Patient candidate for outpatient management.
* Patient who has given free and informed consent.
* Patient who has signed the consent form.
* Patient affiliated or beneficiary of a health insurance plan.

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* History of inflammatory bowel disease, Crohn's disease.
* Failure of a previous colonoscopy.
* Known familial polyposis.
* Contraindication to polypectomy (coagulation disorder, treatment with CLOPIDOGREL / anticoagulant).

Primary outcomes:
measure: Compare colonic adenoma detection rates (CADR) during colonoscopy between the three groups
timeFrame: Day 0
Secondary outcomes:
measure: Operator effect on CADR, between the three groups, per operator
timeFrame: Day 0
measure: CADR according to adenoma size, for each strategy
timeFrame: Day 0
measure: CADR according to adenoma histology for each strategy.
timeFrame: Day 0
measure: CADR according to adenoma morphology for each strategy.
timeFrame: Day 0
measure: Shrinkage time for the Genius groups.
timeFrame: Day 0
measure: Rate of cecal intubation between groups
timeFrame: Day 0
measure: Progression time between groups
timeFrame: Day 0
measure: Operative time between groups
timeFrame: Day 0
measure: The number of immediate intra- and postoperative adverse events (bleeding, perforation) according to the different strategies
timeFrame: Day 0
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Ludovic Caillo
role: PRINCIPAL_INVESTIGATOR
References: