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

NCT05171634 | Completed DMC

• 1 other identifier: CEIm: 62.21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis; Dysplasia

Keywords

Virtual chromoendoscopy; Artificial intelligence; iSCAN; Dysplasia

Outcome Measures

Primary Outcomes (2)

• "Per lesion" dysplasia detection rate (DDR)

  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.

  Immediately after the procedure.

• "Per patient" dysplasia detection rate (DDR)

  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.

  Immediately after the procedure.

Study Arms (2)

Colonoscopy assisted by DiscoveryTM

EXPERIMENTAL

Device: DiscoveryTM

Virtual Colonoscopy with iSCAN

ACTIVE COMPARATOR

Device: iSCAN

Interventions

DiscoveryTM DEVICE

Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).

Colonoscopy assisted by DiscoveryTM

iSCAN DEVICE

Virtual colonoscopy assisted by iSCAN

Virtual Colonoscopy with iSCAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead
• University of Valencia: collaborator

Study Sites (1)

Antonio López-Serrano

Valencia, 46017, Spain

Location

Related Publications (1)

• Lopez-Serrano A, Voces A, Lorente JR, Santonja FJ, Algarra A, Latorre P, Del Pozo P, Paredes JM. Artificial intelligence for dysplasia detection during surveillance colonoscopy in patients with ulcerative colitis: A cross-sectional, non-inferiority, diagnostic test comparison study. Gastroenterol Hepatol. 2025 Feb;48(2):502210. doi: 10.1016/j.gastrohep.2024.502210. Epub 2024 May 11. English, Spanish.

  PMID: 38740327 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endoscopy

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: December 29, 2021
• Study Start: May 5, 2021
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)