Initial Case Series With Exalt Single-Use Duodenoscope

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:

Initial Case Series With Exalt Single-Use Duodenoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701958
• Other study ID #: E7145
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: June 7, 2019

Study information

• Verified date: August 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 7, 2019
• Est. primary completion date: May 6, 2019
• 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 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 ERCP procedure performed with the Exalt single use duodenoscope study device.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Ronald Reagan 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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful 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 qualitative rating	Endoscopist rating of the Exalt single-use duodenoscope compared to their past experience with marketed reusable duodenoscopes as it pertains to various design and performance related attributes.	Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours on study day 1).
Secondary	Incidence of 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.	Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).
Secondary	Evaluation of adverse events (SAEs) related to the device and/or the procedure		SAEs are assessed through 7 days after the procedure.