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Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial

NCT06895785 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-26

No results posted yet for this study

Summary

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.

Conditions

  • Biliary Diseases
  • Pancreatic Duct Disorder

Interventions

DEVICE

Exalt Model D

Exalt Model D single-use duodenoscope will be used in ERCP

DEVICE

Reusable

Standard reusable duodenoscope will be used in ERCP

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Neal A Mehta, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2030-02-28
Completion
2030-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06895785 on ClinicalTrials.gov