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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2021-05-18

Brief Summary

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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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Detailed Description

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Conditions

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Ulcerative Colitis Dysplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Colonoscopy assisted by DiscoveryTM

Group Type EXPERIMENTAL

DiscoveryTM

Intervention Type DEVICE

Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).

Virtual Colonoscopy with iSCAN

Group Type ACTIVE_COMPARATOR

iSCAN

Intervention Type DEVICE

Virtual colonoscopy assisted by iSCAN

Interventions

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DiscoveryTM

Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).

Intervention Type DEVICE

iSCAN

Virtual colonoscopy assisted by iSCAN

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No