Global Prospective Case Series Using a Single-Use Duodenoscope

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Intervention / Treatment: Device: Exalt Model D Single-Use Duodenoscope

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 551
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • Metro North Hospital and Health Services
• Canada
  • Toronto, Canada, M5B 1W8
    • St. Michael's Hospital - Unity Health
• France
  • Marseille, France
    • Institut Paoli-Calmettes
• Germany
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany
      • Evangelisches Krankenhaus Düsseldorf
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• India
  • Telangana
    • Hyderabad, Telangana, India
      • Asian Institute of Gastroenterology
  • West Bengal
    • Kolkata, West Bengal, India, 700054
      • Apollo Multispeciality Hospitals
• Italy
  • Milan, Italy
    • Humanitas University
• Netherlands
  • Rotterdam, Netherlands, 3015 CN
    • Erasmus University Medical Center of Rotterdam
• Singapore
  • Singapore, Singapore
    • Singapore General Hospital
• South Africa
  • Ga-Rankuwa, South Africa
    • Dr. George Mukhari Academic Hospital
• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indianapolis University Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10065
      • Cornell Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exalt DScope 02; Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).
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.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Marco Bruno, MD, PhD, Erasmus Medical Center; Principal Investigator: Adam Slivka, MD, PhD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: E7156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes