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Procedure

Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC) for Liver and Bile Duct Disease (ICECAP Trial)

N/A
Waitlist Available
Led By Nauzer Forbes, MD MSc
Research Sponsored by University of Calgary
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 immediate
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new medical device with a disposable part to reduce infections in patients undergoing a specific procedure. The disposable part is thrown away after each use, making the device cleaner and safer. The study aims to see if this new device works better and stays cleaner than traditional devices. Single-use devices and those with detachable/disposable parts have emerged in the market to reduce the risk of infections related to this procedure.

Eligible Conditions
  • Liver and Bile Duct Disease
  • Biliary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ERCP technical success rate
Persistent bacterial contamination rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)Experimental Treatment1 Intervention
Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)
Group II: Pentax ED-34i10T DuodenoscopeActive Control1 Intervention
Pentax ED-34i10T Duodenoscope
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ERCP procedure with Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)
2019
N/A
~520

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaOTHER
972 Previous Clinical Trials
7,398,782 Total Patients Enrolled
University of CalgaryLead Sponsor
809 Previous Clinical Trials
885,863 Total Patients Enrolled
Nauzer Forbes, MD MScPrincipal InvestigatorUniversity of Calgary
3 Previous Clinical Trials
29,572 Total Patients Enrolled
~88 spots leftby Nov 2025
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