Endoscopic Retrograde Cholangiopancreatography
Conditions
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.
Interventions
Subjects will have a clinically indicated per standard of care ERCP procedure performed with the Exalt single use duodenoscope study device.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Evaluation of adverse events (SAEs) related to the device and/or the procedure | SAEs are assessed through 7 days after the procedure. | — |
Countries
United States
Outcome results
None listed