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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Oct 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether using two advanced tools together—the ENDOCUFF VISION® endoscopy cap and the GI GENIUS™ artificial intelligence (AI) system—can improve the detection of precancerous growths called colonic adenomas during colonoscopy. Colorectal cancer is a serious condition, and finding and removing these adenomas early is key to prevention. The researchers believe that by combining these two devices, they can enhance the ability of doctors to spot these lesions better than when using either device alone.

To participate in this trial, individuals aged 65 to 74 who need a colonoscopy for screening may be eligible if they have certain risk factors, such as a positive fecal test or a family history of polyps or colorectal cancer. Participants will receive a colonoscopy where the effectiveness of the combined tools in detecting adenomas will be assessed. It's important to note that patients with certain medical histories or conditions may not qualify for this study. Overall, this trial aims to improve colorectal cancer screening, ultimately saving lives through better detection and treatment of precancerous conditions.

Gender

ALL

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).