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Global Prospective Case Series Using a Single-Use Duodenoscope

NCT04103749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 551

Last updated 2023-12-12

Study results available
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Summary

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

Conditions

  • Endoscopic Retrograde Cholangiopancreatography

Interventions

DEVICE

Exalt Model D Single-Use Duodenoscope

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Adam Slivka, MD, PhD · University of Pittsburgh Medical Center

  • Marco Bruno, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2022-11-23
Completion
2023-01-05
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Netherlands
  • Singapore
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103749 on ClinicalTrials.gov