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Can a new basket catheter clear large bile duct stones better?

NCT ID NCT05363345

Disease control Sponsor: Akira Horiuchi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial compares two devices used to remove large bile duct stones (10 mm or larger): the Vortic Catch V basket catheter and a standard basket catheter. The goal is to see which device clears more stones completely and whether one is faster or safer. About 100 people with known or suspected large bile duct stones will be randomly assigned to one of the two devices during a procedure called endoscopic papillary large balloon dilation. The study will measure how many stones are cleared, total procedure time, and any complications within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vortic Catch V basket catheter (a specialized device for removing bile duct stones)
What this could lead to
If the Vortic Catch V basket catheter proves more effective, it could offer a better option for clearing large bile duct stones in a single procedure, potentially reducing the need for repeat treatments.
What could go wrong
This is a relatively small trial, and the new device may not outperform the standard basket. There are also risks of complications like bleeding, infection, or injury to the bile duct during the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

choledocholithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Randomized study

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Showa Inan General hospital

    RECRUITING

    Komagane, Nagano, 399-4191, Japan

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