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

NCT ID: NCT04456218

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Biliary Tract Neoplasms Stone - Biliary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Biliary stone

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Biliary stricture

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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.).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chiao-Hsiung Chuang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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A-BR-108-097

Identifier Type: -

Identifier Source: org_study_id

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