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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05171634

Acronym

CUDISIA

Enrollment

Registered

2021-12-29

Start date

2021-05-05

Completion date

2021-05-18

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia, Ulcerative Colitis

Keywords

Virtual chromoendoscopy, Artificial intelligence, iSCAN, Dysplasia

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.

Interventions

DEVICEDiscoveryTM

Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).

DEVICEiSCAN

Virtual colonoscopy assisted by iSCAN

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Per lesion dysplasia detection rate (DDR)	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.
Per patient dysplasia detection rate (DDR)	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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026