Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Initial Case Series With Exalt Single-Use Duodenoscope

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03701958
Recruitment Status : Completed
First Posted : October 10, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Endoscopic Retrograde Cholangiopancreatography Device: Exalt Model D Single-Use Duodenoscope Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Initial Case Series With Exalt Single-Use Duodenoscope
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : May 6, 2019
Actual Study Completion Date : June 7, 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Successful ERCP procedure [ Time Frame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1). ]
    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.


Secondary Outcome Measures :
  1. Endoscopist qualitative rating [ Time Frame: 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). ]
    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.

  2. Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope [ Time Frame: Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1). ]
    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.

  3. Evaluation of adverse events (SAEs) related to the device and/or the procedure [ Time Frame: SAEs are assessed through 7 days after the procedure. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701958


Locations
Layout table for location information
United States, California
Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Layout table for investigator information
Principal Investigator: V. Raman Muthusamy, MD University of California, Los Angeles
Principal Investigator: Andrew Ross, MD Virginia Mason Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03701958    
Other Study ID Numbers: E7145
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No