Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Lauren Grimm
grimml@ccf.org
216-444-4650
Time Frame
Start Date: 2023-08-29
Estimated Completion Date: 2026-03
Participants
Target number of participants: 90
Treatments
Active_comparator: vacuum-assisted sheath
Active_comparator: passive suction via conventional sheath
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic