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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456218
• Other study ID #: A-BR-108-097
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Biliary Tract
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Neoplasms
• Stone - Biliary

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A complete common bile duct accessing rate	To test the device's feasibility	1 day
Primary	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).	1 day
Secondary	Number of complications (ablation, bleeding, perforation in percentage) or system malfunction	To test the device's safety	1 day
Secondary	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)	1 day
Secondary	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.	1 day