Global Prospective Case Series Using a Single-Use Duodenoscope
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 551
- Locations
- 22
- Primary Endpoint
- Number of Participants With Successful ERCP Procedure
Study Overview
Brief Summary
Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based 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. Up to 1000 cases will be included at up to 40 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 30 days after their procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
Exalt DScope 02
Subjects will have a clinically indicated per standard of care 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.
Intervention: Exalt Model D Single-Use Duodenoscope (Device)
Outcomes
Primary Outcomes
Number of Participants With 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.
Secondary Outcomes
- Endoscopist Rating(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 Adverse Events (SAEs) Related to the Device and/or the Procedure(SAEs are assessed through 30 days after the procedure.)
- Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope(Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).)