Home › Kidney Stones › NCT05993546
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Recruiting
Who can join
Ages 18 and older · All sexes
Full 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 study
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.
What is being tested
- vacuum assisted sheath (device)
- passive suction via conventional sheath (device)
Sponsor: The Cleveland Clinic · Participants: 90 · Started: Aug 29, 2023
Contact the study team
- Lauren Grimm · Phone: 216-444-4650
Official record on ClinicalTrials.gov — NCT05993546
Locations in the U.S.
| Ohio | Cleveland Clinic, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.