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
|Condition or disease||Intervention/treatment||Phase|
|Endoscopic Retrograde Cholangiopancreatography||Device: Exalt Model D Single-Use Duodenoscope||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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|
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.
- 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.
- 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.
- 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.
- Evaluation of adverse events (SAEs) related to the device and/or the procedure [ Time Frame: SAEs are assessed through 7 days after the procedure. ]
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
|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|
|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|
|Principal Investigator:||V. Raman Muthusamy, MD||University of California, Los Angeles|
|Principal Investigator:||Andrew Ross, MD||Virginia Mason Medical Center|