- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223830
Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience
March 8, 2022 updated by: Boston Scientific Corporation
The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rotterdam, Netherlands
- Erasmus Medical Center
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California
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Los Angeles, California, United States, 90095
- University of California Los Angeles Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
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New York
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 endoscopic retrograde cholangiopancreatography (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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Exalt DScope 01B
Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (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.
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Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
Time Frame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope
Time Frame: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.
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Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes.
The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better).
A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes.
A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes.
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Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.
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Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope
Time Frame: Crossover is monitored throughout the procedure (within 24 hours on study day 1).
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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.
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Crossover is monitored throughout the procedure (within 24 hours on study day 1).
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Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure
Time Frame: SAEs are assessed through 7 days after the procedure.
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Number of serious adverse events (SAEs) related to the device and/or the procedure.
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SAEs are assessed through 7 days after the procedure.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 14, 2020
Primary Completion (ACTUAL)
February 22, 2021
Study Completion (ACTUAL)
March 1, 2021
Study Registration Dates
First Submitted
January 3, 2020
First Submitted That Met QC Criteria
January 8, 2020
First Posted (ACTUAL)
January 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- E7158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data, analytic methods, and study materials for this study may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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