Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience
1 other identifier
interventional
200
2 countries
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2020
CompletedFirst Posted
Study publicly available on registry
January 10, 2020
CompletedStudy Start
First participant enrolled
January 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedResults Posted
Study results publicly available
March 31, 2022
CompletedMarch 31, 2022
March 1, 2022
1.1 years
January 3, 2020
February 3, 2022
March 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (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 Outcomes (3)
Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope
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 Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope
Crossover is monitored throughout the procedure (within 24 hours on study day 1).
Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure
SAEs are assessed through 7 days after the procedure.
Study Arms (1)
Exalt DScope 01B
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of California Los Angeles Medical Center
Los Angeles, California, 90095, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Erasmus Medical Center
Rotterdam, Netherlands
Related Publications (1)
Slivka A, Ross AS, Sejpal DV, Petersen BT, Bruno MJ, Pleskow DK, Muthusamy VR, Chennat JS, Krishnamoorthi R, Lee C, Martin JA, Poley JW, Cohen JM, Thaker AM, Peetermans JA, Rousseau MJ, Tirrell GP, Kozarek RA; EXALT Single-use Duodenoscope Study Group. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021 Dec;94(6):1046-1055. doi: 10.1016/j.gie.2021.06.017. Epub 2021 Jun 26.
PMID: 34186052DERIVED
Results Point of Contact
- Title
- Victoria Lazzari
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Slivka, MD, PhD
University of Pittsburgh Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2020
First Posted
January 10, 2020
Study Start
January 14, 2020
Primary Completion
February 22, 2021
Study Completion
March 1, 2021
Last Updated
March 31, 2022
Results First Posted
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
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).