Trials / Completed
CompletedNCT04456218
Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- National Cheng-Kung University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2021-06-30
- Completion
- 2021-12-31
- First posted
- 2020-07-02
- Last updated
- 2022-08-02
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04456218. Inclusion in this directory is not an endorsement.