HoYAG vs TFL in miniPCNL With ClearPetra

Not Applicable

Not yet recruiting

• Conditions: Nephrolithiasis; Kidney Stone

• Registration Number: NCT07087977
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2025-05-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-09-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Males or females over 18 years of age
2. Patients with kidney stones, with stone burden larger than 15 mm.
3. Patients undergoing new percutaneous access with primary, supine, unilateral mini-PCNL.

Exclusion Criteria

4. Simultaneous use of more than 1 laser platform or other form of fragmentation (e.g., ultrasonic).
5. Patients undergoing simultaneous treatment of contralateral kidney stones during the same procedure.
6. Patients undergoing simultaneous treatment of ureteral stones during the same procedure.
7. Pregnant patients.
8. Presence of genitourinary anatomical abnormalities.
9. Uncorrected coagulopathy.
10. External urinary catheters.
11. Immunosuppressed patients.
12. Non-elective procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stone Lithotripsy time between HoYAG and TFL	Procedure	Time from scope insertion to scope removal

Secondary Outcome Measures

Name	Time	Method
Total operative time between HoYAG and TFL	Procedure	Time from time-out to procedure finish
Stone Free Status between ClearPetra and traditional approach	90 days	Stone free is defined as no residual stones larger than 2mm in post operative CT scan
Laser Energy	Procedure	Laser efficiency will be measured by evaluating the laser energy in kilojoules used during the procedure.
Laser Time	Procedure	Laser efficiency will be measured by evaluating the time in minutes the laser was used during the procedure.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States