An interventional study of NCKU-scope-01 (a custom-made biliary endoscope system) in Biliary Tract, Neoplasms and Stone - Biliary, sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Diagnostic
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.
286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.
This study's enrollment of 14 is below the median of 90 across 197 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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.
Device: NCKU-scope-01 (a custom-made biliary endoscope system)
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.
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
A complete common bile duct accessing rate
To test the device's feasibility
Time frame: 1 day
Image quality evaluation: the light brightness and the imaging sharpness in Likert scale
To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).
Time frame: 1 day
Number of complications (ablation, bleeding, perforation in percentage) or system malfunction
To test the device's safety
Time frame: 1 day
In biliary stone arm: The biggest residual stone size (in cm).
The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)
Time frame: 1 day
In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture
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.
Time frame: 1 day
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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National Cheng-Kung University Hospital