Duodenoscope for Biliary Disease

Overseen By Amanda F Lin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Altered anatomy, Pregnancy, Prior ERCP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Exalt Model D, Reusable for biliary disease?

The Exalt Model D, a single-use duodenoscope, has shown equivalent technical performance and provider satisfaction compared to reusable duodenoscopes, while eliminating the risk of device-related infections. This suggests it is effective for procedures like endoscopic retrograde cholangiopancreatography (ERCP), which is used to manage biliary diseases. ^{1 2 3 4 5}

Is the single-use duodenoscope safe for humans?

The single-use duodenoscope, like the EXALT Model D, is designed to reduce the risk of infections that can occur with reusable duodenoscopes. It eliminates the chance of device-related infection transmission, which is a known issue with reusable devices. ^{1 5 6 7 8}

How is the Exalt Model D duodenoscope treatment different from other treatments for biliary disease?

The Exalt Model D duodenoscope is unique because it is a single-use device, which eliminates the risk of infection transmission associated with reusable duodenoscopes. This makes it safer for patients by avoiding the potential for device-related infectious outbreaks. ^{1 2 3 7 9}

What is the purpose of this trial?

This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

Research Team

Neal A Mehta, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for individuals with gallbladder disorders, pancreatic duct dysfunction, or biliary disease. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions relevant to the study.

Inclusion Criteria

My body's natural duct openings are intact.

Exclusion Criteria

Patients with percutaneous transhepatic biliary drainage

Pregnancy

Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ERCP using either the Exalt Model D single-use duodenoscope or the standard reusable duodenoscope

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and infection rates post-ERCP

7 days

1 visit (in-person), follow-up calls

Treatment Details

Interventions

• Exalt Model D
• Reusable

Trial Overview The trial is testing a new disposable duodenoscope called Exalt Model D against traditional reusable scopes. It aims to compare their effectiveness and safety by looking at how easy they are to use, any adverse events that occur, if there's a need to switch between them (crossover events), and infection rates after procedures.

Participant Groups

Group I: Exalt Model D Experimental Treatment 1 Intervention

Exalt Model D single use duodenoscope will be used for ERCP

Group II: Standard Reusable Active Control 1 Intervention

Standard reusable model of duodenoscope will be used for ERCP

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Device profile of the EXALT Model D single-use duodenoscope for endoscopic retrograde cholangiopancreatography: overview of its safety and efficacy. [2021]

2. Japan pubmed.ncbi.nlm.nih.gov

Efficacy and safety of direct peroral cholangioscopy using a new multibending ultra-slim endoscope for the management of biliary diseases. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Single-step direct cholangioscopy by freehand intubation using standard endoscopes for diagnosis and therapy of biliary diseases. [2012]

4. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Use of a novel single-use disposable duodenoscope for ERCP: selected clips from a real-world case series. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cannulation rates and technical performance evaluation of commericially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Analysis of reported adverse events related to single-use duodenoscopes and duodenoscopes with detachable endcaps. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Prospective evaluation of digital single-operator cholangioscope for diagnostic and therapeutic procedures (with videos). [2022]