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OpenTrials
Completed

NCT Number: NCT03701958

Initial Case Series With Exalt Single-Use Duodenoscope

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

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Key information

Conditions

Endoscopic Retrograde Cholangiopancreatography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ronald Reagan University of California Los Angeles Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exalt Model D Single-Use Duodenoscope

Device

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

Primary outcomes

  1. Successful ERCP procedure

    Time frame: Procedure 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 outcomes

  1. Endoscopist qualitative rating

    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).

    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.

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

    Time frame: Incidence of crossover 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.

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

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2018
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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