Improving colon cancer screening with advanced technology
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
This study is testing if using a special endoscopic cap and an artificial intelligence system together can help find more precancerous growths in the colon during screening for people at risk of colon cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 483 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 2 sites (Limoges and 1 other locations) |
| Trial ID | NCT05594576 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of the ENDOCUFF VISION® endoscopic cap and the GI GENIUS™ artificial intelligence system in enhancing the detection rate of colonic adenomas during colonoscopy. By utilizing these innovative tools, the trial aims to determine if their combined use can significantly improve the colonic adenoma detection rate (CADR) compared to using each device alone. The study focuses on patients undergoing colorectal cancer screening, particularly those with risk factors for polyps or colorectal cancer. The ultimate goal is to reduce the incidence and mortality associated with colorectal cancer through improved screening techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals requiring colorectal cancer screening, particularly those with positive fecal immunological tests or a personal/family history of polyps or colorectal cancer.
Not a fit: Patients with a history of inflammatory bowel disease, known familial polyposis, or contraindications to polypectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective screening for colorectal cancer, potentially saving lives through earlier detection of pre-cancerous lesions.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in improving adenoma detection rates.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Limoges and 1 other locations
- CHU de Limoges — Limoges, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Ludovic Caillo — CHU de Nimes
- Study coordinator: Ludovic Caillo
- Email: ludovic.caillo@chu-nimes.fr
- Phone: 04.66.68.37.94
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.