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Completed

NCT Number: NCT04456218

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

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.

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Key information

Conditions

Biliary Tract Biliary Tract Diseases Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Neoplasms Stone - Biliary

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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

Device

The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis

Primary outcomes

  1. A complete common bile duct accessing rate

    Time frame: 1 day

    To test the device's feasibility

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

    Time frame: 1 day

    To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).

Secondary outcomes

  1. Number of complications (ablation, bleeding, perforation in percentage) or system malfunction

    Time frame: 1 day

    To test the device's safety

  2. In biliary stone arm: The biggest residual stone size (in cm).

    Time frame: 1 day

    The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)

  3. In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture

    Time frame: 1 day

    The ability for differential diagnosis of benign or malignant stricture. The specific features include increased vascularity, irregular mucosa/nodularity, luminal narrowing, tumor vessel, mucosal lesion.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2020
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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