Comparing two methods for kidney stone surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure for treating kidney stones. Participants will undergo surgery using either a vacuum-assisted sheath or a standard sheath to access the kidney and remove stones. The study will involve approximately 90 patients at the Cleveland Clinic, with follow-up appointments scheduled 4-6 weeks post-surgery to assess outcomes. Both techniques are commonly used and have demonstrated safety and effectiveness for stones of similar size and location.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Sriharan Sivalingam — Principal Investigator
• Study coordinator: Lauren Grimm
• Email: grimml@ccf.org
• Phone: 216-444-4650

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.