NCT07087977

HoYAG vs TFL in miniPCNL With ClearPetra

Holmium:YAG Laser With MOSES Technology vs Thulium Fiber Laser in Supine Mini-percutaneous Nephrolithotomy With Vacuum-assisted Renal Access Sheath: A Prospective, Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Mini percutaneous nephrolithotripsy is the treatment of choice for kidney stones over 2cm. This procedure commonly uses laser energy for breaking the stones, and among possible laser platforms, Hoyag and thulium fiber laser are FDA approved. Recently, this procedure has also included the use of vacuum assisted renal access sheaths, which allows suction to be employed together with the breaking of stones. This study intends to compare outcomes when using either laser platforms with suction sheaths in participants undergoing mini percutaneous nephrolithotripsy for the treatment of kidney stones.

Detailed description

Due to the reduced diameter sheath of miniaturized percutaneous nephrolithotripsy (miniPCNL), surgical outcomes commonly rely on stone fragmentation provided by a laser energy source. Holmium:yttrium-aluminum-garnet laser (HoYAG) has long been considered the gold-standard for lithotripsy, but this position has been challenged by the introduction of the thulium fiber laser (TFL) since its approval for clinical use in 2017. In the same manner, the recently developed ClearPetra™(MicroTech Endoscopy®, China) vacuum-assisted renal access sheath (VA-RAS) is a novel technology that allows for concomitant irrigation and suction during the procedure. No prior studies to date have exclusively investigated mini-PCNL outcomes with Ho:YAG and TFL when using VA-RAS. This study addresses the literature paucity regarding the outcomes when utilizing the high-power Ho:YAG with MOSES technology vs. TFL in mini-PCNL with VA-RAS. This study hypothesizes that the Ho:YAG may provide more efficient stone clearance, secondary to its superior ability to fragment stones when compared to the TLF laser, which primarily dusts despite the laser settings utilized.

Conditions

• Nephrolithiasis
• Kidney Stone

Interventions

Type	Name	Description
DEVICE	HoYAG laser	Patients will be randomly assigned (1:1) to HoYAG laser or TFL laser group for miniPCNL surgery according to standard of care.
DEVICE	TFL laser platform	Patients will be randomly assigned (1:1) to HoYAG or TFL laser group for MiniPCNL surgery according to standard of care.

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study