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RecruitingNCT05363345Updated Aug 11, 2026

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

An interventional study of bile duct stone removal in Randomized Study, sponsored by Akira Horiuchi. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Akira Horiuchi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2022, registered May 2022).
  • Started Feb 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study summary

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).

02

Conditions studied

  • Randomized Study
03

In context

Lead sponsor

This is the only study on the registry with Akira Horiuchi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Devicebile 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.

06

What researchers measure

Primary outcomes

  1. Percentage of stones cleared

    Percentage of stones cleared is evaluated after the completion of procedure.

    Time frame: Procedure time

Secondary outcomes

  1. Total procedural time

    Total procedure time is measured.

    Time frame: Procedure time

  2. the number of adverse events

    Adverse events are evaluated after the completion of procedure.

    Time frame: Procedure time

  3. the numbers of morbidities and mortality

    Morbidities and mortality is evaluated within 30 days after the completion of procedure.

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Showa Inan General hospital
    Komagane, Nagano 399-4191, Japan
    • Akira Horiuchi, M.D. · Contact · horiuchi.akira@sihp.jp · 81265822121
    • Akira Horiuchi, M.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05363345
Lead sponsor
Akira Horiuchi
Responsible party
Akira Horiuchi (Chief of Digestive Disease Center, Showa Inan General Hospital) — Sponsor-investigator
First posted
May 5, 2022
Start date
Feb 2, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 11, 2026

Study contacts

Akira Horiuchi, MD
Contact
horiuchi.akira@sihp.jp
09021684311 ext. 3012

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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