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

NCT06895785 | Recruiting FDA Device

• 1 other identifier: RUMC-ORA-24022203
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

endoscopic retrograde cholangiopancreatography (ERCP); duodenoscope; single-use; reusable; biliary disorder; pancreatic duct disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  From the time of the ERCP to 7 days post-ERCP per standard of care

Secondary Outcomes (5)

• Crossover single to reusable

  From the start of the ERCP to the end of procedure

• Use of advanced cannulation techniques

  From the start of the ERCP to the end of procedure

• Performance on ERCP maneuvers

  From the start of the ERCP to the end of procedure

• Adverse events

  From the completion of the ERCP to 7 days post-ERCP per standard of care

• Endoscopist-determined ease of use

  From the start of the ERCP to the end of procedure

Study Arms (2)

Exalt Model D

EXPERIMENTAL

Exalt Model D single use duodenoscope will be used for ERCP

Device: Exalt Model D

Standard Reusable

ACTIVE COMPARATOR

Standard reusable model of duodenoscope will be used for ERCP

Device: Reusable

Interventions

Exalt Model D DEVICE

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

Also known as: Single-use duodenoscope

Exalt Model D

Reusable DEVICE

Standard reusable duodenoscope will be used in ERCP

Standard Reusable

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60607, United States

RECRUITING

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Neal A Mehta, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neal A Mehta, MD

CONTACT

3129428651; Neal_A_Mehta@rush.edu

Amanda F Lin

CONTACT

3125633907; amanda_f_lin@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (1)