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

ConditionKidney Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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

Qualifiers

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

Disqualifiers

Anticoagulated or history of coagulopathy

Congenital renal anomalies

Prior ipsilateral upper urinary tract reconstructive procedures

Conversion to open procedure

Trial design

Treatments tested in this trial

  • vacuum assisted sheath
  • passive suction via conventional sheath

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators