Collecting colonoscopy data to develop AI devices
Collecting Real-world Data on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies for the Development of a CAD (Computer Aided Detection) System: a Prospective, Multicenter, Post-market Investigation
Olympus Europe SE & Co. KG · NCT05869838
This study is collecting information from colonoscopy procedures to see if new artificial intelligence tools can help doctors find and treat colon polyps better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Olympus Europe SE & Co. KG (industry) |
| Locations | 3 sites (Hannover and 2 other locations) |
| Trial ID | NCT05869838 on ClinicalTrials.gov |
What this trial studies
This study aims to gather data from routine colonoscopy procedures to aid in the development and evaluation of artificial intelligence devices designed for colonoscopy. During the procedures, biopsies or resections will be performed as necessary, and all specimens will undergo histopathological examination. The collected data will help assess the performance of AI technologies in identifying and managing colonic polyps.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for a colonoscopy for screening or surveillance purposes.
Not a fit: Patients requiring urgent colonoscopy or those with contraindications for the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and efficiency of colonoscopy procedures through improved AI-assisted diagnostics.
How similar studies have performed: Other studies have shown promise in using AI for colonoscopy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older * Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study * Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam Exclusion Criteria: * Patients for whom endoscopic submucosal dissection is planned * Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc. * Patients who have to receive an urgent colonoscopy procedure * Patients who underwent total colectomy of the large intestine * Patients who are judged by a physician to be contraindicated for colonoscopy procedures * Patients who have participated in another clinical study within the last 30 days
Where this trial is running
Hannover and 2 other locations
- End- und Dickdarmzentrum Hannover — Hannover, Germany (COMPLETED)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (RECRUITING)
- Ersta Hospital Stockholm — Stockholm, Sweden (WITHDRAWN)
Study contacts
- Principal investigator: Sofía Parejo Carbonell — Hospital Universitario Ramón y Cajal
- Study coordinator: Swaantje Hoffstedt
- Email: swaantje.hoffstedt@olympus.com
- Phone: +49 40 23773 9351
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.
Conditions: Colonic Polyp