N/A
N=200
Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience
Endoscopic Retrograde Cholangiopancreatography
Bottom Line
View on ClinicalTrials.gov: NCT04223830 ↗Enrolled (actual)
200
Serious AEs
6.5%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure — 193 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
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure |
193 | — |
| SECONDARY Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope |
7.6 | — |
| SECONDARY Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope |
19 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure |
15 | — |
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.
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 endoscopic retrograde cholangiopancreatography (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
Data sourced from ClinicalTrials.gov (NCT04223830). 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.