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

Not Applicable
Completed
Conditions
Endoscopic Retrograde Cholangiopancreatography
Interventions
Device: Exalt Model D Single-Use Duodenoscope
Registration Number
NCT04223830
Lead Sponsor
Boston Scientific Corporation
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Exalt DScope 01BExalt Model D Single-Use DuodenoscopeSubjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) ProcedureProcedure success is assessed at the end of the procedure (within 24 hours on study day 1).

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.

Secondary Outcome Measures
NameTimeMethod
Endoscopist Overall Satisfaction Rating of the Exalt Single-use DuodenoscopeEndoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.

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.

Number of Serious Adverse Events (SAEs) Related to the Device and/or the ProcedureSAEs are assessed through 7 days after the procedure.

Number of serious adverse events (SAEs) related to the device and/or the procedure.

Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable DuodenoscopeCrossover is monitored throughout the procedure (within 24 hours on study day 1).

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.

Trial Locations

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

University of Pittsburgh Medical Center

🇺🇸

Pittsburgh, Pennsylvania, United States

Virginia Mason Medical Center

🇺🇸

Seattle, Washington, United States

Erasmus Medical Center

🇳🇱

Rotterdam, Netherlands

University of California Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
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