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Endoscope

Exalt Model D Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography

N/A
Waitlist Available
Led By Adam Slivka, MD, PhD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
Awards & highlights

Study Summary

This trial found that the ExaltTM Model D Single-Use Duodenoscope worked just as well as a traditional duodenoscope for performing endoscopic retrograde cholangio-pancreatography and other duodenoscope-based procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).
This trial's timeline: 3 weeks for screening, Varies for treatment, and incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Successful ERCP Procedure
Secondary outcome measures
Endoscopist Rating
Number of Adverse Events (SAEs) Related to the Device and/or the Procedure
Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope

Trial Design

1Treatment groups
Experimental Treatment
Group I: Exalt DScope 02Experimental Treatment1 Intervention
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exalt Model D Single-Use Duodenoscope
2019
N/A
~820

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
719 Previous Clinical Trials
932,519 Total Patients Enrolled
Adam Slivka, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh Medical Center
1 Previous Clinical Trials
200 Total Patients Enrolled
Marco Bruno, MD, PhDPrincipal InvestigatorErasmus Medical Center
2 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Global Prospective Case Series Using a Single-Use Duodenoscope
2021. "Global Prospective Case Series Using a Single-Use Duodenoscope". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04103749.
~135 spots leftby Apr 2025
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