Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
The Cleveland Clinic
90 participants
Aug 29, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
conventional access sheath for stone retrieval using current technique via passive suction
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05993546