Randomized StudyNCT05363345
Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones
A study testing bile duct stone removal in people with Randomized Study, run by Akira Horiuchi at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Randomized Study
- What is being tested?
- bile duct stone removal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 2 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm)
- endoscopic papillary balloon dilation (EPLBD) was performed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Showa Inan General hospital
Komagane, Nagano, 399-4191
Akira Horiuchi, M.D., 81265822121 ext. 3012, horiuchi.akira@sihp.jp
Akira Horiuchi, M.D.
About this study
Official title: 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).
- Conditions
- Randomized Study
- Being tested
- bile duct stone removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: bile duct stone removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of stones cleared
Percentage of stones cleared is evaluated after the completion of procedure.
Measured: Procedure time
Secondary outcomes (3)
Total procedural time
Total procedure time is measured.
Measured: Procedure time
the number of adverse events
Adverse events are evaluated after the completion of procedure.
Measured: Procedure time
the numbers of morbidities and mortality
Morbidities and mortality is evaluated within 30 days after the completion of procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start2 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akira Horiuchi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Akira Horiuchi, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363345
- Sponsor's protocol ID
- Vortic Catch V
- Status last verified
- Aug 2026
- First submitted
- 2 May 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones
- ClinicalTrials.gov ID
- NCT05363345
- Acronym / sponsor ID
- Vortic Catch V
- Conditions
- Randomized Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Akira HoriuchiUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vortic Catch V basket catheter | Experimental | Device: bile duct stone removalCommon bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter following endoscopic papillary large balloon dilation. |
| ordinary basket catheter | Active comparator | Device: bile duct stone removalCommon bile duct stones (≧ 10 mm) are removed by using ordinary basket catheter following endoscopic papillary large balloon dilation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm)
- endoscopic papillary balloon dilation (EPLBD) was performed.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bile duct stone removalCommon bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter or ordinary basket catheter following endoscopic papillary large balloon dilation. | Device | Vortic Catch V basket catheter, ordinary basket catheter |
Primary outcome
Percentage of stones cleared
Time frame: Procedure time
Percentage of stones cleared is evaluated after the completion of procedure.
3 secondary outcomes
Total procedural time
Time frame: Procedure time
the number of adverse events
Time frame: Procedure time
the numbers of morbidities and mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bile duct stone removal in people with Randomized Study, run by Akira Horiuchi at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akira Horiuchi, MD (09021684311 ext. 3012, horiuchi.akira@sihp.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of stones cleared (time frame: Procedure time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.