RecruitingNot Applicable

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

United States90 participantsStarted 2023-08-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Aim 1: Stone free rate

Timeframe: 6 weeks

Aim 2: Intraoperative variables

Timeframe: 3-7 days

Aim 3: Post-operative Outcomes and Complications

Timeframe: 1 day

Trial details

NCT IDNCT05993546

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Lauren Grimm

216-444-4650 grimml@ccf.org

View on ClinicalTrials.gov More Kidney Stone trials