Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Launched by THE CLEVELAND CLINIC · Aug 7, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different methods for a surgical procedure called mini-percutaneous nephrolithotomy (mini-PCNL), which is used to treat kidney stones. Specifically, the study is comparing the use of a vacuum-assisted sheath with a standard sheath during the surgery. Both methods are commonly used and have been shown to be safe and effective for removing kidney stones that are similar in size and location to yours.
If you are between 18 and 74 years old and have kidney stones that are between 10 and 25 mm in size, you might be eligible to participate. You would need to be able to provide informed consent and be willing to follow the study's requirements. Participants will undergo the mini-PCNL procedure and will be monitored for how well each method works in removing the stones. This study is currently recruiting participants, and it aims to help improve the treatment options available for kidney stones.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with planned prone mini-PCNL and a preoperative NCCT
- • Primary stone size: 10-25 mm
- • Pre-existing indwelling nephrostomy tube or ureteral stent permitted
- • Age: ≥ 18 years old
- • Gender: all
- • Ethnicity: all
- • Capable of giving informed consent
- • Capable and willing to fulfill requirements of the study
- Exclusion Criteria:
- • Anticoagulated or history of coagulopathy
- • Congenital renal anomalies
- • Prior ipsilateral upper urinary tract reconstructive procedures
- • Conversion to open procedure
- • Multiple access tracts
- • Inability to give informed consent or unable to meet requirements of the study for any reason
About The Cleveland Clinic
The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
Trial Officials
Sriharan Sivalingam
Principal Investigator
Principal Investigator
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported