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

March 19, 2025 updated by: Neal Ambrish Mehta, Rush University Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To ensure a safe and high-quality endoscopy, there are multiple disinfection protocols for endoscopes. Side-viewing duodenoscopes with an adjustable accessory device (elevator) contain potential blind spots for debris and bacteria that require specialized cleaning and disinfection methods beyond standard protocols for other endoscopes. It is thought that the duodenoscope's design, persistent postprocedural microbial contamination and biofilm formation make it more prone to cross-contamination5. Gromski et al, found there are documented pathogenic transmissions, which led to harm in multiple patients and centers3. Infection control was likely related to two major components, reusable duodenoscopes and procedural factors related to how the reusable duodenoscopes were reprocessed3. Multidrug-resistant organisms, such as carbapenem-resistant Enterobacteriaceae, that were associated with reusable duodenoscopes lead the FDA to mandate the transition to improved cleaning and disinfection methods or single-use platforms to eliminate infection transmission. One such single-use platform is the Exalt Model D (Boston Scientific, Marlboro, MA), which received FDA approval in 2020 for use of single-use duodenoscopes. Early iterations of the Exalt were used on a case-by-case basis per institution-specific protocols, mainly due to the learning curve involved with using the scope. A new version of Exalt has been released to market in 2023 with modifications that may make it more feasible to use in all settings requiring a duodenoscope. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Rush University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients > 18 years old who have biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at CT or magnetic resonance cholangiopancreatography
  • Native papilla

Exclusion Criteria:

  • Patients with altered pancreaticobiliary anatomy
  • Pregnancy
  • Patients with percutaneous transhepatic biliary drainage
  • Prior history of ERCP
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exalt Model D
Exalt Model D single use duodenoscope will be used for ERCP
Device: Exalt Model D
Exalt Model D single-use duodenoscope will be used in ERCP
Other Names:
  • Single-use duodenoscope
Active Comparator: Standard Reusable
Standard reusable model of duodenoscope will be used for ERCP
Device: Reusable
Standard reusable duodenoscope will be used in ERCP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of attempts required to achieve successful cannulation of the desired duct
Time Frame: From the time of the ERCP to 7 days post-ERCP per standard of care
Measure and compare the total number of attempts required to achieve successful cannulation of the desired duct.
From the time of the ERCP to 7 days post-ERCP per standard of care

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Crossover single to reusable
Time Frame: From the start of the ERCP to the end of procedure
The incidence of crossovers from single-use duodenoscope to reusable duodenoscope
From the start of the ERCP to the end of procedure
Use of advanced cannulation techniques
Time Frame: From the start of the ERCP to the end of procedure
The utilization of advanced cannulation techniques in ERCP procedure
From the start of the ERCP to the end of procedure
Performance on ERCP maneuvers
Time Frame: From the start of the ERCP to the end of procedure
Subjective ratings on 14 ERCP maneuvers. ("not preferred/neutral/preferred" relative to the reusable duodenoscope endoscopist usually uses in clinical practice), 23 device performance characteristics. (Likert scale of 1 [not preferred] to 5 [comparable with reusable duodenoscope])
From the start of the ERCP to the end of procedure
Adverse events
Time Frame: From the completion of the ERCP to 7 days post-ERCP per standard of care
Post- ERCP pancreatitis, post-sphincterotomy bleed, and infection at 72 hours and 7 days post-ERCP procedure per Standard of Care.
From the completion of the ERCP to 7 days post-ERCP per standard of care
Endoscopist-determined ease of use
Time Frame: From the start of the ERCP to the end of procedure
Median overall satisfaction with the single-use duodenoscope during the procedure (Likert scale of 1 [unsatisfied] to 10 [very satisfied], followed by the option "If you answered ≤ 5, specify reason")
From the start of the ERCP to the end of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Neal A Mehta, MD, Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RUMC-ORA-24022203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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