Global Prospective Case Series Using a Single-Use Duodenoscope

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:

Global Prospective Case Series Using a Single-Use Duodenoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103749
• Other study ID #: E7156
• Status: Completed
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: January 5, 2023

Study information

• Verified date: November 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based 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. Up to 1000 cases will be included at up to 40 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 30 days after their procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: January 5, 2023
• Est. primary completion date: November 23, 2022
• 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:

• 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 or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.

Locations

Country	Name	City	State
Australia	Metro North Hospital and Health Services	Brisbane
Canada	St. Michael's Hospital - Unity Health	Toronto
France	Institut Paoli-Calmettes	Marseille
Germany	Evangelisches Krankenhaus Düsseldorf	Düsseldorf	North Rhine-Westphalia
Hong Kong	Prince of Wales Hospital	Hong Kong
India	Asian Institute of Gastroenterology	Hyderabad	Telangana
India	Apollo Multispeciality Hospitals	Kolkata	West Bengal
Italy	Humanitas University	Milan
Netherlands	Erasmus University Medical Center of Rotterdam	Rotterdam
Singapore	Singapore General Hospital	Singapore
South Africa	Dr. George Mukhari Academic Hospital	Ga-Rankuwa
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Indianapolis University Hospital	Indianapolis	Indiana
United States	University of California Los Angeles Medical Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Cornell Medical Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Hong Kong,  India,  Italy,  Netherlands,  Singapore,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 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 Rating	Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best)	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 a 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	Number of Adverse Events (SAEs) Related to the Device and/or the Procedure	Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope based procedures	SAEs are assessed through 30 days after the procedure.