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Completed

NCT Number: NCT05171634

Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)

Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Dysplasia Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonio López-Serrano

Valencia, 46017, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ulcerative Colitis confirmed by endoscopy and histology.
  • Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
  • Duration of the disease >7 years (or any duration if concomitant with PSC).

Exclusion criteria

  • Personal history of colorectal cancer or high-grade dysplasia.
  • Previous colectomy (partial or complete).
  • Coagulopathy that prevents biopsies or polypectomy.
  • Colonoscopy performed in the previous 6 months.
  • Pregnant or nursing women.
  • Inadequate bowel preparation.
  • Presence of endoscopic Ulcerative Colitis activity.
  • Colonic stenosis and incomplete colonoscopy.

Treatment and study plan

DiscoveryTM

Device

Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).

iSCAN

Device

Virtual colonoscopy assisted by iSCAN

Primary outcomes

  1. "Per lesion" dysplasia detection rate (DDR)

    Time frame: Immediately after the procedure.

    Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.

  2. "Per patient" dysplasia detection rate (DDR)

    Time frame: Immediately after the procedure.

    Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.

Sponsors and collaborators

Lead sponsor

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Other

Collaborators

  • University of Valencia

Registry information

Official study title

Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study

Acronym: CUDISIA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2021
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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