NCT04223830

Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.

Detailed description

The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.

Conditions

• Endoscopic Retrograde Cholangiopancreatography

Interventions

Type	Name	Description
DEVICE	Exalt Model D Single-Use Duodenoscope	Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.

Timeline

• Start date: 2020-01-14
• Primary completion: 2021-02-22
• Completion: 2021-03-01
• First posted: 2020-01-10
• Last updated: 2022-03-31
• Results posted: 2022-03-31

Locations

7 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated device study