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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am older than 18 years.

Select...

I am having an ERCP for a bile duct or pancreatic condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with procedure-related adverse events

Secondary outcome measures

Ability to perform interventions

Duodenoscope imaging characteristics profile

Duodenoscope maneuverability

+1 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,340,755 Total Patients Enrolled

Subhas Banerjee, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been invited to partcipate in this clinical research?

"Indeed, clinicaltrials.gov data reveals that this research is actively recruiting patients. The trial was first posted on October 25th 2022 and has been updated recently on the 24th of October 2022. 600 participants are being sought at a single medical centre."

Answered by AI

Are there any openings to partake in this trial at present?

"In accordance with clinicaltrials.gov, this trial is actively enlisting participants; the study was posted on October 25th 2022 and its details were updated most recently on October 24th 2022."

Answered by AI

Recent research and studies

Digestive EndoscopyJournal

Prospective Evaluation of an Assessment Tool for Technical Performance of Duodenoscopes

Bang, Ji Young, Thomas Rösch, Hyungjin Myra Kim, Shyam Thakkar, Ernesto Robalino Gonzaga, Benjamin Tharian, Sumant Inamdar, et al.. 2020. “Prospective Evaluation of an Assessment Tool for Technical Performance of Duodenoscopes”. Digestive Endoscopy. Wiley. doi:10.1111/den.13856.

clinicaltrials.govStudy

Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

Subhas Banerjee 2022. "Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429203.

All > Pancreas Cancer > Pancreatic Cancer