N/A
N=551
Global Prospective Case Series Using a Single-Use Duodenoscope
Endoscopic Retrograde Cholangiopancreatography
Bottom Line
View on ClinicalTrials.gov: NCT04103749 ↗Enrolled (actual)
551
Serious AEs
15.4%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants With Successful ERCP Procedure — 529 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exalt Model D Single-Use Duodenoscope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful ERCP Procedure |
529 | — |
| SECONDARY Endoscopist Rating |
8.0 | — |
| SECONDARY Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope |
37 | — |
| SECONDARY Number of Adverse Events (SAEs) Related to the Device and/or the Procedure |
46 | — |
Summary
Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04103749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.