Clinical trial · Interventional
Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
NCT04456218CI-TRIAL-00060022completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Stone - Biliary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NCKU-scope-01 (a custom-made biliary endoscope system) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Biliary stone
- description
- 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.
- interventionNames
- Device: NCKU-scope-01 (a custom-made biliary endoscope system)
- type
- EXPERIMENTAL
- label
- Biliary stricture
- description
- 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.
- interventionNames
- Device: NCKU-scope-01 (a custom-made biliary endoscope system)
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available
No reference posted for this study.