NCT05363345

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Feb 2022Dec 2026

Study Start

First participant enrolled

February 2, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

4.9 years

First QC Date

May 2, 2022

Last Update Submit

May 14, 2025

Conditions

Randomized Study

Outcome Measures

Primary Outcomes (1)

  • Percentage of stones cleared

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

    Procedure time

Secondary Outcomes (3)

  • Total procedural time

    Procedure time

  • the number of adverse events

    Procedure time

  • the numbers of morbidities and mortality

    30 days

Study Arms (2)

Vortic Catch V basket catheter

EXPERIMENTAL

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

ordinary basket catheter

ACTIVE COMPARATOR

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

bile duct stone removalDEVICE

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.

Vortic Catch V basket catheterordinary basket catheter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General hospital

Komagane, Nagano, 399-4191, Japan

RECRUITING

Central Study Contacts

Akira Horiuchi, MD

CONTACT

09021684311horiuchi.akira@sihp.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Digestive Disease Center

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 5, 2022

Study Start

February 2, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)