Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones

May 14, 2025 updated by: Akira Horiuchi

Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones

Investigators will perform randomized trial of the removal ability with Vortic Catch V basket catheter versus ordinary basket catheter for bile duct stones (≧ 10 mm).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Nagano
      • Komagane, Nagano, Japan, 399-4191
        • Recruiting
        • Showa Inan General Hospital
        • Contact:
        • Principal Investigator:
          • Akira Horiuchi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm)
  • endoscopic papillary balloon dilation (EPLBD) was performed.

Exclusion Criteria:

  • septic shock
  • coagulopathy (international normalized ratio 1.3, partial thromboplastin time greater than twice that of control),
  • <platelet count 50,000 / L
  • suspected or confirmed malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vortic Catch V basket catheter
Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter following endoscopic papillary large balloon dilation.
Device: bile duct stone removal
Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter or ordinary basket catheter following endoscopic papillary large balloon dilation.
Active Comparator: ordinary basket catheter
Common bile duct stones (≧ 10 mm) are removed by using ordinary basket catheter following endoscopic papillary large balloon dilation.
Device: bile duct stone removal
Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter or ordinary basket catheter following endoscopic papillary large balloon dilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of stones cleared
Time Frame: Procedure time
Percentage of stones cleared is evaluated after the completion of procedure.
Procedure time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total procedural time
Time Frame: Procedure time
Total procedure time is measured.
Procedure time
the number of adverse events
Time Frame: Procedure time
Adverse events are evaluated after the completion of procedure.
Procedure time
the numbers of morbidities and mortality
Time Frame: 30 days
Morbidities and mortality is evaluated within 30 days after the completion of procedure.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akira Horiuchi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Vortic Catch V

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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