Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study)

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Dysplasia
• Interventions: Device: CADe system; Device: NBI

• Registration Number: NCT06281392
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Brief Summary

Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-11-27
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-11-15
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colonoscopy assisted by CADe	CADe system	-
Virtual Colonoscopy with NBI	NBI	-

Primary Outcome Measures

Name	Time	Method
"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 (CADe) or Virtual chromoendoscopy with NBI in patients with long-standing Inflammatory bowel disease 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 Inflammatory bowel disease included in the study detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI

Secondary Outcome Measures

Name	Time	Method
Duration of endoscopic examination	Immediately after the procedure	Median (IQR) examination time (in minutes) (including total, insertion, and withdrawal time) required by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI

Trial Locations

Locations (1)

Antonio López-Serrano; 🇪🇸 Valencia, Spain