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Initial Case Series With Exalt Single-Use Duodenoscope

NCT03701958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-02-08

No results posted yet for this study

Summary

To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

Conditions

  • Endoscopic Retrograde Cholangiopancreatography

Interventions

DEVICE

Exalt Model D Single-Use Duodenoscope

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • V. Raman Muthusamy, MD · University of California, Los Angeles

  • Andrew Ross, MD · Virginia Mason Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2019-05-06
Completion
2019-06-07

Countries

  • United States

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 NCT03701958 on ClinicalTrials.gov