Initial Case Series With Exalt Single-Use Duodenoscope
- Conditions
- Endoscopic Retrograde Cholangiopancreatography
- Interventions
- Device: Exalt Model D Single-Use Duodenoscope
- Registration Number
- NCT03701958
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 01 Exalt Model D Single-Use Duodenoscope 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.
- Primary Outcome Measures
Name Time Method Successful 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 Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope 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.
Endoscopist qualitative rating 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.
Evaluation of adverse events (SAEs) related to the device and/or the procedure SAEs are assessed through 7 days after the procedure.
Trial Locations
- Locations (6)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Ronald Reagan University of California Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States