Using AI to improve polyp detection during colonoscopy
Prospective Randomized Study on the Use of Artificial Intelligence (Fujifilm) for Polyp Detection in Colonoscopy
NA · Universitätsklinikum Hamburg-Eppendorf · NCT04894708
This study is testing whether using artificial intelligence during colonoscopy can help doctors find more polyps, especially the smaller ones, in people over 35.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1572 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Locations | 10 sites (Kassel, Hessen and 9 other locations) |
| Trial ID | NCT04894708 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an artificial intelligence system developed by Fujifilm in enhancing polyp detection during colonoscopy procedures. By integrating AI with high-resolution imaging devices, the study aims to improve the adenoma detection rate, which is crucial for preventing colorectal cancer. Participants will undergo a planned diagnostic or screening colonoscopy, where the AI system will be randomly applied to assess its impact on identifying polyps, particularly smaller and flat adenomas that are often missed. The study will include individuals over the age of 35 who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 35 years old who are scheduled for a diagnostic or screening colonoscopy.
Not a fit: Patients with known polyps for removal, inflammatory bowel disease, or those who have undergone colon cancer surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of colorectal cancer by improving the detection of polyps during colonoscopy.
How similar studies have performed: Previous studies have shown promising results with AI applications in endoscopy, indicating that this approach is both novel and has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persons\> 35 years of age who are capable of giving informed consent * Planned diagnostic colonoscopy (clarification of symptoms, polyp follow-up) * Screening colonoscopy for men \>50 or women \> 55 years of age Exclusion Criteria: * Colon bleeding * Colon carcinoma * Known polyps for removal * Inflammatory bowel disease * Colonic stenosis * Other suspected colon disease for further clarification * Follow-up care after colon cancer surgery (partial colon resection) * Anticoagulant drugs that make a biopsy or polypectomy impossible * Poor general condition (ASA IV) * Incomplete colonoscopy planned
Where this trial is running
Kassel, Hessen and 9 other locations
- Gastroenterologiepraxis Dr. Moog — Kassel, Hessen, Germany (TERMINATED)
- Universitätsklinikum Leipzig — Leipzig, Sachsen, Germany (RECRUITING)
- GastroZentrum Lippe — Bad Salzuflen, Germany (TERMINATED)
- Gastroenterologie am Bayerischen Platz — Berlin, Germany (RECRUITING)
- University Hospital Bonn — Bonn, Germany (RECRUITING)
- University Hospital Eppendorf — Hamburg, Germany (RECRUITING)
- St. Vinzenz-Hospital / Akademisches Lehrkrankenhaus der Universität zu Köln — Köln, Germany (RECRUITING)
- University Hospital Magdeburg — Magdeburg, Germany (RECRUITING)
- Marienhospital Osnabrück — Osnabrück, Germany (RECRUITING)
- Asklepios Paulinen Klinik Wiesbaden — Wiesbaden, Germany (RECRUITING)
Study contacts
- Principal investigator: Thomas Rösch, Prof. dr. — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Thomas Rösch, Prof. Dr.
- Email: t.roesch@uke.de
- Phone: +49 40 7410
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: Screening Colonoscopy, Colonoscopic Control After Polypectomy, Suspected Colon Polyps