NCT06709209Recruiting
AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis
A Novel Simplified Endoscopic Score aiMed at Evaluating Ulcerative cOlitis Activity Through TXI, RDI and NBI Vascular Assessment and at prEdicting Clinical Outcome and Its Applicability in an arTificial Intelligence System: the MONET Study
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- 4 Nov 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- University College Cork
- Diseases
- Ulcerative colitis
- NCT number
- NCT06709209
What you commit to
- Study type: Observational
- Planned participants: 300
- From 4 Nov 2024 to the primary completion date, 30 Sept 2026
- 11 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- If the participant has been in a recent experimental trial, these must have been completed not less than thirty days prior to this study
Other
- Contraindications to endoscopy (including toxic megacolon) and biopsies (including severe coagulopathy/thrombocytopenia)
- Poor bowel preparation (defined as total BBPS \<6 or BBPS \<2 in observed segment for sigmoidoscopy)
- Significant co-morbidities limiting life expectancy and conferring high risk of endoscopy
- Pregnant and breast-feeding subjects
- Inability to provide informed consent
Who the study is looking for
- Adult patients aged 18 to 75 years old
- Established diagnosis of UC (for at least six months in duration), independently from their active treatment
- Undergoing endoscopy for disease activity assessment or cancer surveillance.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Klinikum Luneburg Coordinator of this site? Confirm its status | Lüneburg | Germany | Not yet recruiting |
| University College Cork Coordinator of this site? Confirm its status | Cork | Ireland | Recruiting |
| University of Bari Coordinator of this site? Confirm its status | Bari | Italy | Not yet recruiting |
| Ospedale S. Maria del Prato Coordinator of this site? Confirm its status | Feltre | Italy | Not yet recruiting |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| University Vita-Salute San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| University of Naples Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| University of Pavia Coordinator of this site? Confirm its status | Pavia | Italy | Not yet recruiting |
| Showa University Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| Changi General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.