Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience
- Conditions
- Endoscopic Retrograde Cholangiopancreatography
- Interventions
- Device: Exalt Model D Single-Use Duodenoscope
- Registration Number
- NCT04223830
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exalt DScope 01B Exalt Model D Single-Use Duodenoscope 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure 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
Name Time Method 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. 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.
Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure SAEs are assessed through 7 days after the procedure. Number of serious adverse events (SAEs) related to the device and/or the procedure.
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). 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.
Trial Locations
- Locations (7)
University of California Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
University of California Los Angeles Medical Center🇺🇸Los Angeles, California, United States