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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05779436
Other study ID # 23-000450
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date September 2026

Study information

Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old - Anticipation that patient may undergo POC during an endoscopic retrograde cholangioscopy - Pregnant patients can be included in the study. Use of the POC-CNN does not convey any new risk to the patient nor fetus. - Non-English speaking subjects will be included in the study. Consent for the procedure itself is always done with the assistance of an interpreter via telephone or video. Use of the POC-CNN will be discussed with all patients via this interpreter during the procedure consent. Exclusion Criteria: - Age <18 years old - No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP) - Prisoner

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota
United States University of Massachusetts Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary POC-CNN Model AUC Area Under the Curve (AUC) analysis for POC-CNN for classification of malignant biliary stricture Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Secondary Test characteristics of POC-CNN Sensitivity and Specificity of POC-CNN for the diagnosis of malignant biliary stricture, Sensitivity and Specificity of biliary brushings and biliary biopsies Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
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