Trials / Completed
CompletedNCT04103749
Global Prospective Case Series Using a Single-Use Duodenoscope
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 551 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures
Detailed description
This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. Up to 1000 cases will be included at up to 40 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 30 days after their procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Exalt Model D Single-Use Duodenoscope | Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device. |
Timeline
- Start date
- 2021-03-22
- Primary completion
- 2022-11-23
- Completion
- 2023-01-05
- First posted
- 2019-09-25
- Last updated
- 2023-12-12
- Results posted
- 2023-12-12
Locations
22 sites across 11 countries: United States, Australia, Canada, France, Germany, Hong Kong, India, Italy, Netherlands, Singapore, South Africa
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04103749. Inclusion in this directory is not an endorsement.