Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
1 other identifier
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 2, 2022
July 1, 2022
12 months
June 14, 2020
July 29, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
A complete common bile duct accessing rate
To test the device's feasibility
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).
1 day
Secondary Outcomes (3)
Number of complications (ablation, bleeding, perforation in percentage) or system malfunction
1 day
In biliary stone arm: The biggest residual stone size (in cm).
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
1 day
Study Arms (2)
Biliary stone
EXPERIMENTALParticipants 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.
Biliary stricture
EXPERIMENTALParticipants 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.
Interventions
The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis
Eligibility Criteria
You may qualify if:
- Patients with complicated bile duct stone (stone size \> 1.5 cm or number of stone \> 3 )
- Patients with indeterminate biliary stricture or obstruction
You may not qualify if:
- Pregnant woman;
- Patients who are not suitable for ERCP (e.g. behavior disorder, major cognitive-perceptual deficit, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University Hospital
Tainan, 704, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 14, 2020
First Posted
July 2, 2020
Study Start
July 1, 2020
Primary Completion
June 30, 2021
Study Completion
December 31, 2021
Last Updated
August 2, 2022
Record last verified: 2022-07