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Trial 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
NCT ID:
NCT05594576
Condition:
Colorectal Cancer
Adenoma
Intestinal Polyps
Conditions: Official terms:
Adenoma
Intestinal Polyps
Conditions: Keywords:
colonoscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
GI GENIUS™ artificial intelligence system
Description:
Device used during coloscopy for detection of colonic adenoma
Arm group label:
ENDOCUFF VISION® Endoscopic Cap coupled with GI GENIUS™ Artificial Intelligence (AI)
Arm group label:
GI GENIUS™ Artificial Intelligence (AI) alone
Intervention type:
Procedure
Intervention name:
ENDOCUFF VISION® endoscopic cap
Description:
Device used during coloscopy for detection of colonic adenoma
Arm group label:
ENDOCUFF VISION® Endoscopic Cap coupled with GI GENIUS™ Artificial Intelligence (AI)
Arm group label:
ENDOCUFF VISION® endoscopic cap alone
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Limoges
Address:
City:
Limoges
Zip:
87000
Country:
France
Status:
Recruiting
Contact:
Last name:
Jérémie JACQUES
Phone:
0555058772
Email:
Jeremie.jacques@chu-limoges.fr
Facility:
Name:
CHU de Nîmes
Address:
City:
Nîmes
Country:
France
Status:
Recruiting
Contact:
Last name:
Anissa Megzari
Phone:
04.66.68.42.36
Email:
drc@chu-nimes.fr
Contact backup:
Last name:
Ludovic CAILLO
Contact backup:
Last name:
Jean-François BOURGAUX
Contact backup:
Last name:
Philippe POUDEROUX
Contact backup:
Last name:
Clémentine CLERC
Contact backup:
Last name:
Bénédicte BRUNAUD-GAGNIARD
Contact backup:
Last name:
Thomas BORDERIE
Start date:
October 18, 2022
Completion date:
November 2024
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Nīmes
Agency class:
Other
Collaborator:
Agency:
University Hospital, Limoges
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Nīmes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05594576
