Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06709209

AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis

Led by University College Cork · Updated on 2024-12-03

300

Participants Needed

11

Research Sites

151 weeks

Total Duration

On this page

Sponsors

U

University College Cork

Lead Sponsor

O

Olympus

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 to 75 years old
  • Established diagnosis of ulcerative colitis for at least six months
  • Undergoing endoscopy for disease activity assessment or cancer surveillance
Not Eligible

You will not qualify if you...

  • Contraindications to endoscopy or biopsies, including toxic megacolon and severe coagulopathy or thrombocytopenia
  • Poor bowel preparation defined as total BBPS score less than 6 or BBPS less than 2 in the observed segment for sigmoidoscopy
  • Significant co-morbidities limiting life expectancy or posing high risk for endoscopy
  • Pregnant or breastfeeding
  • Inability to provide informed consent
  • Participation in an experimental trial within the past 30 days

AI-Screening

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Trial Site Locations

Total: 11 locations

1

University of Leuven

Leuven, Belgium

Not Yet Recruiting

2

Klinikum Luneburg

Lüneburg, Germany

Not Yet Recruiting

3

University College Cork

Cork, Co Cork, Ireland

Actively Recruiting

4

Ospedale S. Maria del Prato

Feltre, Belluno, Italy

Not Yet Recruiting

5

University of Bari

Bari, Italy

Not Yet Recruiting

6

Istituto Clinico Humanitas

Milan, Italy

Not Yet Recruiting

7

University Vita-Salute San Raffaele

Milan, Italy

Not Yet Recruiting

8

University of Naples

Naples, Italy

Actively Recruiting

9

University of Pavia

Pavia, Italy

Not Yet Recruiting

10

Showa University

Tokyo, Japan

Not Yet Recruiting

11

Changi General Hospital

Singapore, Singapore

Not Yet Recruiting

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Research Team

M

Michelle O'Riordan

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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