Actively Recruiting
Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones
Led by Akira Horiuchi · Updated on 2025-05-15
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the ability to remove large bile duct stones (10 mm or larger) using two different basket catheter devices. The study evaluates the Vortic Catch V basket catheter against an ordinary basket catheter following a procedure called endoscopic papillary large balloon dilation. The trial is randomized and designed to assess which device is more effective in clearing the stones during the procedure. Participants will undergo removal of common bile duct stones using either the Vortic Catch V basket catheter or the ordinary basket catheter after receiving endoscopic papillary large balloon dilation. The two groups receive these different devices in a randomized manner to compare their performance directly. During the study, researchers will measure the percentage of stones successfully cleared and the total procedure time. They will also monitor the number of adverse events and complications, including morbidities and mortality over a 30-day period. This helps evaluate both the effectiveness and safety of the devices during and after the treatment.
CONDITIONS
Brief Title
Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients suspected or known to have common bile duct stones 10 mm or larger
- Endoscopic papillary balloon dilation (EPLBD) was performed
You will not qualify if you...
- Septic shock
- Coagulopathy (international normalized ratio above 1.3 or partial thromboplastin time more than twice control)
- Platelet count less than 50,000 per microliter
- Suspected or confirmed malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo bile duct stone removal using either the Vortic Catch V basket catheter or ordinary basket catheter following endoscopic papillary large balloon dilation.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored for adverse events, morbidities, and mortality after the stone removal procedure.
Follow-up visits as needed within 30 days
Trial Site Locations
Total: 1 location
1
Showa Inan General hospital
Komagane, Nagano, Japan, 399-4191
Actively Recruiting
Research Team
A
Akira Horiuchi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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