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

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

Status: Completed

Conditions: Dysplasia; Ulcerative Colitis

Treatments: Device: iSCAN; Device: DiscoveryTM

Study type: Interventional

Funder types: Other

Identifiers

NCT05171634

CEIm: 62.21

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Colonoscopy assisted by DiscoveryTM

Experimental group

Treatment:

Device: DiscoveryTM

Virtual Colonoscopy with iSCAN

Active Comparator group

Treatment:

Device: iSCAN