CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 551 enrolled
Drug / intervention
Exalt Model D Single-Use Duodenoscopedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04103749
NCT04103749N/ACompleted
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Global Prospective Case Series Using a Single-Use Duodenoscope

Boston Scientific Corporation·interventional·Posted Sep 25, 2019·Updated Dec 12, 2023

In Brief

A clinical study evaluating Exalt Model D Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Completed, enrolled 551 participants across 22 sites in 11 countries.

Detailed Summary

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndoscopic Retrograde Cholangiopancreatography
CountriesAustralia, Canada, France, Germany, Hong Kong, India, Italy, Netherlands, Singapore, South Africa, United States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 25, 2019
Enrollment StartMar 22, 2021
Primary CompletionNov 23, 2022
Study CompletionJan 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.8 years ago

Interventions

Exalt Model D Single-Use Duodenoscopedevice

Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.