Trials / Completed
CompletedNCT03701958
Initial Case Series With Exalt Single-Use Duodenoscope
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) 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. 35-70 cases will be included at up to 10 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 7 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 procedure performed with the Exalt single use duodenoscope study device. |
Timeline
- Start date
- 2019-04-15
- Primary completion
- 2019-05-06
- Completion
- 2019-06-07
- First posted
- 2018-10-10
- Last updated
- 2022-02-08
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03701958. Inclusion in this directory is not an endorsement.