HoYAG vs TFL in miniPCNL With ClearPetra

University of Kansas

Status: Not yet enrolling

Conditions: Kidney Stone; Nephrolithiasis

Treatments: Device: TFL laser platform; Device: HoYAG laser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07087977

STUDY00161413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

MiniPCNL with HoYAG

Active Comparator group

Description:

In Arm 1, participants will undergo miniPCNL with ClearPetra™ vacuum-assisted ureteral access sheath with HoYAG laser platform. Participants will undergo miniPCNL per standard of care

Treatment:

Device: HoYAG laser

MiniPCNL with TFL

Active Comparator group

Description:

In Arm 2, participants will undergo miniPCNL with ClearPetra™ vacuum-assisted ureteral access sheath with TFL laser platform. Participants will undergo miniPCNL per standard of care

Treatment:

Device: TFL laser platform