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

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223830
• Other study ID #: E7158
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Willing and able to comply with the study procedures and provide written informed consent to participate in the study

• Scheduled for a clinically indicated endoscopic retrograde cholangiopancreatography (ERCP)

Exclusion Criteria:

• Altered pancreaticobiliary anatomy

• Potentially vulnerable subjects, including, but not limited to pregnant women

• Subjects for whom endoscopic techniques are contraindicated

• Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor

• Investigator discretion

Related Conditions & MeSH terms

• Endoscopic Retrograde Cholangiopancreatography

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of California Los Angeles Medical Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure	The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure".; Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.	Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
Secondary	Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope	Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes. The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better). A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes.	Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.
Secondary	Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope	The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.	Crossover is monitored throughout the procedure (within 24 hours on study day 1).
Secondary	Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure	Number of serious adverse events (SAEs) related to the device and/or the procedure.	SAEs are assessed through 7 days after the procedure.