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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06281392
Other study ID # CEIm: 106/23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date November 15, 2026

Study information

Verified date February 2024
Source Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Contact Antonio López-Serrano, PhD
Phone +0034656495490
Email anlopezs@comv.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 122
Est. completion date November 15, 2026
Est. primary completion date November 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility INCLUSION CRITERIA: - Adults (age =18 years). - Patients with IBD meeting the following criteria: - Diagnosis of IBD confirmed by clinical and histological evidence. - Disease extent (Montreal classification): 1) For Ulcerative Colitis (UC), Extensive colitis (E3): involvement proximal to the splenic flexure; or, Left-sided colitis (E2): involvement distal to the splenic flexure. 2) For Crohn's Disease (CD): Colon-only involvement (L2); or, Ileocolonic involvement (L3). - Disease duration > 7 years. - Patients with concommitant Primary Sclerosing Cholangitis, regardless of the extent of colonic involvement and disease duration. - Written consent from the patient to undergo colonoscopy (signed informed consent). EXCLUSION CRITERIA: - Personal history of colorectal cancer (CRC). - Previous colectomy (partial or complete). - Coagulopathy preventing biopsy or polypectomy/mucosal resection. - Colonoscopy performed in the last 6 months. - Pregnant or lactating women. - Ulcerative colitis with involvement limited to the rectum or Proctitis (Montreal E1). - Inadequate colonic preparation due to uncleavable fecal residue during colonoscopy: Boston Bowel Preparation Scale (BBPS) = 0 or 1 in any colon segment. - Presence of inflammatory activity due to IBD on endoscopy:1) For UC: Endoscopic Mayo Score = 2. 2) For CD: Simplified Endoscopic Activity Score (SES-CD) > 5. - Incomplete lower digestive endoscopy (failure to reach the cecum).

Study Design


Intervention

Device:
CADe system
Colonoscopy assisted by an artificial intelligence system (CADe).
NBI
Virtual colonoscopy assisted by NBI

Locations

Country Name City State
Spain Antonio López-Serrano Valencia

Sponsors (2)

Lead Sponsor Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary "Per lesion" dysplasia detection rate (DDR) 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 Immediately after the procedure
Primary "Per patient" dysplasia detection rate (DDR) 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 Immediately after the procedure
Secondary Duration of endoscopic examination Median (IQR) examination time (in minutes) (including total, insertion, and withdrawal time) required by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI Immediately after the procedure
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