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Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

RecruitingNAAges 18 Years - anyAllThe Cleveland Clinic
NCT05993546 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • vacuum assisted sheath
  • passive suction via conventional sheath
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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