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NCT05993546
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Conditions: Kidney Stone
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Cleveland Ohio
Summary
The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.
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
Source: ClinicalTrials.gov (NCT05993546). StuddyBuddy aggregates publicly available trial information.