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OpenTrials
Completed

NCT Number: NCT04103749

Global Prospective Case Series Using a Single-Use Duodenoscope

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based 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

Metro North Hospital and Health Services, Brisbane, Australia

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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. Up to 1000 cases will be included at up to 40 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 30 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

  • 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 or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.

Primary outcomes

  1. Number of Participants With 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 Rating

    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.

    Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best)

  2. Number of Participants With a 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. Number of Adverse Events (SAEs) Related to the Device and/or the Procedure

    Time frame: SAEs are assessed through 30 days after the procedure.

    Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope based procedures

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 25, 2019
Registry last updated
Dec 12, 2023

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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