A Single-Use Duodenoscope in a Real-World Setting
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective, Non-Randomized, Single-Arm, Post-Market Observational StudyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.
This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.
Tracking Information
- NCT #
- NCT04628949
- Collaborators
- Ambu Inc.
- Covance
- Investigators
- Study Director: Elizabeth Smith Ambu Inc.