Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

Boston Scientific Corporation200 enrolled

Overview

The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.

The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

200

Conditions

Endoscopic Retrograde Cholangiopancreatography

Interventions

Exalt Model D Single-Use DuodenoscopeDEVICE

Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based 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 endoscopic retrograde cholangiopancreatography (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 (7)

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

Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (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 Overall Satisfaction Rating of the Exalt Single-use Duodenoscope

Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes. The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better). A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes.

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

Number of Participants With 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: Crossover is monitored throughout the procedure (within 24 hours on study day 1).

Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure

Number of serious 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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