CompletedNot Applicable

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

Taiwan14 participantsStarted 2020-07-01

Plain-language summary

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.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.).

What they're measuring

A complete common bile duct accessing rate

Timeframe: 1 day

Image quality evaluation: the light brightness and the imaging sharpness in Likert scale

Timeframe: 1 day

Trial details

NCT IDNCT04456218

SponsorNational Cheng-Kung University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Biliary Tract trials