Initial Case Series With Exalt Single-Use Duodenoscope

N/ACompletedNCT03701958

Boston Scientific Corporation60 enrolled

Overview

To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. 35-70 cases will be included at up to 10 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 7 days after their procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Endoscopic Retrograde Cholangiopancreatography

Interventions

Exalt Model D Single-Use DuodenoscopeDEVICE

Subjects will have a clinically indicated per standard of care ERCP procedure performed with the Exalt single use duodenoscope study device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older * Willing and able to comply with the study procedures and provide written informed consent to participate in the study. * Scheduled for a clinically indicated ERCP Exclusion Criteria: * Altered pancreaticobiliary anatomy * Potentially vulnerable subjects, including, but not limited to pregnant women * Subjects for whom endoscopic techniques are contraindicated * Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor * Investigator discretion

Locations (6)

Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

North Shore University Hospital

Manhasset, New York, United States

Outcomes

Primary Outcomes

Successful ERCP procedure

The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.

Time frame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).

Secondary Outcomes

Endoscopist qualitative rating

Endoscopist rating of the Exalt single-use duodenoscope compared to their past experience with marketed reusable duodenoscopes as it pertains to various design and performance related attributes.

Time frame: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours on study day 1).

Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope

The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.

Time frame: Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).

Evaluation of adverse events (SAEs) related to the device and/or the procedure

Time frame: SAEs are assessed through 7 days after the procedure.

Data from ClinicalTrials.gov

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