Biliary DiseasesNCT06895785
Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
A study testing Exalt Model D and Reusable in people with Biliary Diseases and Pancreatic Duct Disorder, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Diseases, Pancreatic Duct Disorder
- What is being tested?
- Exalt Model D and Reusable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with altered pancreaticobiliary anatomy
- Pregnancy
- Patients with percutaneous transhepatic biliary drainage
- Prior history of ERCP
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60607
Amanda F Lin, 3125633907, amanda_f_lin@rush.edu
About this study
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.
Read the 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.
- Conditions
- Biliary Diseases, Pancreatic Duct Disorder
- Being tested
- Exalt Model D, Reusable
- Keywords
- endoscopic retrograde cholangiopancreatography (ERCP), duodenoscope, single-use, reusable, biliary disorder, pancreatic duct disorder
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exalt Model DDevice
Also called Single-use duodenoscope
Exalt Model D single-use duodenoscope will be used in ERCP
ReusableDevice
Standard reusable duodenoscope will be used in ERCP
| Study group | Role | What they receive |
|---|---|---|
| Exalt Model D | Experimental | Exalt Model D single use duodenoscope will be used for ERCP Receives: Device: Exalt Model D |
| Standard Reusable | Active comparator | Standard reusable model of duodenoscope will be used for ERCP Receives: Device: Reusable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts required to achieve successful cannulation of the desired duct
Measure and compare the total number of attempts required to achieve successful cannulation of the desired duct.
Measured: From the time of the ERCP to 7 days post-ERCP per standard of care
Secondary outcomes (5)
Crossover single to reusable
The incidence of crossovers from single-use duodenoscope to reusable duodenoscope
Measured: From the start of the ERCP to the end of procedure
Use of advanced cannulation techniques
The utilization of advanced cannulation techniques in ERCP procedure
Measured: From the start of the ERCP to the end of procedure
Performance on ERCP maneuvers
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])
Measured: From the start of the ERCP to the end of procedure
Adverse events
Post- ERCP pancreatitis, post-sphincterotomy bleed, and infection at 72 hours and 7 days post-ERCP procedure per Standard of Care.
Measured: From the completion of the ERCP to 7 days post-ERCP per standard of care
Endoscopist-determined ease of use
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")
Measured: From the start of the ERCP to the end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start21 Feb 2025
- Primary completionFeb 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Ambrish Mehta, Rush University Medical Center
- Investigators
- Neal A Mehta, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895785
- Sponsor's protocol ID
- RUMC-ORA-24022203
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06895785
- Acronym / sponsor ID
- RUMC-ORA-24022203
- Conditions
- Biliary Diseases, Pancreatic Duct Disorder
- Keywords
- endoscopic retrograde cholangiopancreatography (ERCP), duodenoscope, single-use, reusable, biliary disorder, pancreatic duct disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exalt Model D | Experimental | Device: Exalt Model DExalt Model D single use duodenoscope will be used for ERCP |
| Standard Reusable | Active comparator | Device: ReusableStandard reusable model of duodenoscope will be used for ERCP |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Patients with altered pancreaticobiliary anatomy
- Pregnancy
- Patients with percutaneous transhepatic biliary drainage
- Prior history of ERCP
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exalt Model DAlso: Single-use duodenoscopeExalt Model D single-use duodenoscope will be used in ERCP | Device | Exalt Model D |
| ReusableStandard reusable duodenoscope will be used in ERCP | Device | Standard Reusable |
Primary outcome
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.
5 secondary outcomes
Crossover single to reusable
Time frame: 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
Performance on ERCP maneuvers
Time frame: 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
Endoscopist-determined ease of use
Time frame: From the start of the ERCP to the end of procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neal A Mehta, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exalt Model D and Reusable in people with Biliary Diseases and Pancreatic Duct Disorder, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neal A Mehta, MD (3129428651, Neal_A_Mehta@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.