Recruiting

Exalt Model

Sponsor:

Rush University Medical Center

Code:

NCT06895785

Conditions

Biliary Diseases

Pancreatic Duct Disorder

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Exalt Model D

Reusable

Study Details

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

Study ID

NCT06895785

Start date

Feb 21, 2025

Status verified date

Mar, 2025

Completion date

May, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Exalt Model D

Exalt Model D single use duodenoscope will be used for ERCP

active comparator: Standard Reusable

Standard reusable model of duodenoscope will be used for ERCP

Interventions

Exalt Model D

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

Reusable

Standard reusable duodenoscope will be used in ERCP

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 ]

Central Contacts and Locations

Central contacts

Neal A Mehta, MD

3129428651Neal_A_Mehta@rush.edu

Amanda F Lin

3125633907amanda_f_lin@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Amanda F Lin

3125633907amanda_f_lin@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Mar 26, 2025

Last verified

Mar, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-03-26.