Trials / Completed
CompletedNCT03421340
Non-Complex Biliary Stones DSC vs ERC
Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangiography (ERC).
Detailed description
The objective of this study is to prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangioscopy (ERC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DSC | Stone removal without fluoroscopy using the SpyGlass device. |
| DEVICE | ERC | Standard of care stone removal with fluoroscopy. |
Timeline
- Start date
- 2018-09-21
- Primary completion
- 2023-09-18
- Completion
- 2023-10-08
- First posted
- 2018-02-05
- Last updated
- 2025-01-17
- Results posted
- 2024-11-08
Locations
8 sites across 4 countries: United States, India, Italy, Thailand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03421340. Inclusion in this directory is not an endorsement.