Status:
RECRUITING
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Lead Sponsor:
The Cleveland Clinic
Conditions:
Kidney Stone
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ston...
Detailed Description
In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05993546
Start Date
August 29 2023
End Date
June 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195