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Single-Use vs Reusable Duodenoscopes for Biliary and Pancreatic Diseases

N/A
Recruiting
Led By Subhas Banerjee, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years old
Patients undergoing ERCP for biliary and pancreatic conditions
Must not have
Patients who are unable to consent
Surgically altered anatomy except for Billroth I
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the success and complication rates of two types of endoscopes currently used for a procedure called ERCP.

Who is the study for?
This trial is for adults over 18 who need an ERCP, a special procedure for issues with bile or pancreatic ducts. It's not for pregnant women, those unable to consent, patients with certain infections like CRE or MDRO, or those with complex surgical alterations of the digestive system.
What is being tested?
The study compares two tools used in ERCP: one is a duodenoscope with a single-use cover and the other is the standard reusable version. The goal is to see which one has better success rates and fewer complications.
What are the potential side effects?
While specific side effects are not listed for this trial, typical risks of ERCP include pancreatitis, infections, bleeding, and perforation of the stomach or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am having an ERCP for a bile duct or pancreatic condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent by myself.
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I have had surgery that changed my body's structure, but not a Billroth I procedure.
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I have been diagnosed with cholangitis.
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I have an infection with a bacteria resistant to many antibiotics.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with procedure-related adverse events
Secondary study objectives
Ability to perform interventions
Duodenoscope imaging characteristics profile
Duodenoscope maneuverability
+1 more

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: Conventional DuodenoscopeActive Control1 Intervention
Patients will undergo ERCP using a conventional duodenoscope
Group II: Duodenoscope with single-use distal coverActive Control1 Intervention
Patients will undergo ERCP using a duodenoscope with a single-use distal cover

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,340 Total Patients Enrolled
Subhas Banerjee, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
50 Total Patients Enrolled
~23 spots leftby Dec 2024
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