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Completed

NCT Number: NCT04223830

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

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.

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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

Erasmus Medical Center, Rotterdam, Netherlands

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About this study

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.

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 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

Treatment and study plan

Exalt Model D Single-Use Duodenoscope

Device

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.

Primary outcomes

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

    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 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.

  2. Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope

    Time frame: 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 Serious Adverse Events (SAEs) Related to the Device and/or the Procedure

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

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2020
Registry last updated
Mar 31, 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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