NCT07072598

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.

Detailed description

With the advent of mini-PCNLs, some endourologists have been utilizing the technique to treat renal calculi up to 3cm in size with better stone free rates and similar comorbidity compared to ureteroscopy. These procedures require percutaneous renal access, and it is associated with greater length of stay and fluoroscopy time. The ClearPETRA ureteral access sheath has shown great promise with improving stone free rates, decreasing intra-renal pressure and delivering some of the benefits of mini-PCNL without the added risk associated with obtaining percutaneous renal access. The ClearPETRA flexible suction ureteral access sheath anecdotally improves efficiency and allows endourologists to better clear stone debris when compared to traditional ureteral access sheaths. We have yet to see a comparison between suction ureteral access sheaths and mini-PCNL with the suction renal access sheath. Study Hypothesis: Compared to traditional access sheaths, using ClearPETRA access sheaths will result in an improvement in stone free rates with both modalities, with lower complications. Using ClearPETRA access sheaths in both modalities compared to traditional access sheaths should result in less of a difference in stone free rates between the ureteroscopy group and the mini-PCNL group.

Conditions

• Kidney Stones
• Nephrolithiasis
• Urolithiasis

Interventions

Type	Name	Description
DEVICE	ClearPETRA suction access sheath	Ureteroscopy utilizing the ClearPETRA suction access sheath.
DEVICE	ClearPETRA suction access sheath	Mini-PCNL utilizing the ClearPETRA suction access sheath

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-07-18
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study