Comparing Stone-Free Rates and Efficiency After Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopy Using ClearPETRA Suction Access Sheaths

What this Trial Is About

Researchers are comparing two methods for treating kidney stones ureteroscopy using the ClearPETRA suction ureteral access sheath and mini-percutaneous nephrolithotomy mini-PCNL with suction access sheaths. This study aims to assess and compare the rates of complete stone removal with both procedures, which are commonly used for stones up to 3 cm in size. The ClearPETRA sheath is designed to improve stone clearance and reduce complications compared to traditional access methods. Participants are randomly assigned to receive either ureteroscopy or mini-PCNL using ClearPETRA suction access sheaths. The ureteroscopy procedure involves inserting a flexible scope and using a high-power Holmium laser to break up stones, with stone fragments removed through the suction sheath and a ureteral stent placed afterward. The mini-PCNL procedure begins with cystoscopy and percutaneous renal access under fluoroscopy, followed by tract dilation and stone removal using lithotripsy, suction, or basket extraction, also concluding with a ureteral stent placement. During the study, participants will undergo assessments including a CT scan to confirm stone size before treatment and evaluation of stone-free status four weeks after the procedure. Researchers will monitor surgery time, complications, hospital stays, need for additional procedures, and costs related to the procedure and any follow-up care. Follow-up will last up to 90 days after surgery to track unplanned hospital visits and other outcomes, ensuring comprehensive evaluation of both treatment methods.

Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS