Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract

National Cheng-Kung University

Status: Completed

Conditions: Biliary Tract; Neoplasms; Stone - Biliary

Treatments: Device: NCKU-scope-01 (a custom-made biliary endoscope system)

Study type: Interventional

Funder types: Other

Identifiers

NCT04456218

A-BR-108-097

Details and patient eligibility

About

A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.

Enrollment: 14 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with complicated bile duct stone (stone size > 1.5 cm or number of stone > 3 )
• Patients with indeterminate biliary stricture or obstruction

Exclusion criteria

• Pregnant woman;
• Patients who are not suitable for ERCP (e.g. behavior disorder, major cognitive-perceptual deficit, etc.).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Biliary stone

Experimental group

Description:

Participants who meet the criteria of biliary stone enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.

Treatment:

Device: NCKU-scope-01 (a custom-made biliary endoscope system)

Biliary stricture

Experimental group

Description:

Participants who meet the criteria of biliary neoplasm enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.

Treatment:

Device: NCKU-scope-01 (a custom-made biliary endoscope system)