Initial Case Series With Exalt Single-Use Duodenoscope

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan University of California Los Angeles Medical Center
  • 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
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • 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
• Genders Eligible for Study: All

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Exalt DScope 01; Subjects will have a clinically indicated per standard of care ERCP 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 procedure performed with the Exalt single use duodenoscope study device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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).
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).
Evaluation of adverse events (SAEs) related to the device and/or the procedure		SAEs are assessed through 7 days after the procedure.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: V. Raman Muthusamy, MD, University of California, Los Angeles; Principal Investigator: Andrew Ross, MD, Virginia Mason Medical Center

Publications and helpful links

General Publications

• Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): May 6, 2019
• Study Completion (ACTUAL): June 7, 2019

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (ACTUAL): October 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: E7145

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: No