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NCT Number: NCT07087977

HoYAG vs TFL in miniPCNL With ClearPetra

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.

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Key information

Conditions

Nephrolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stone Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Bristol Whiles, MD

PRINCIPAL_INVESTIGATOR

Jane Ledesma

CONTACT

[email protected]

913-588-8721

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

HoYAG laser

Device

Patients will be randomly assigned (1:1) to HoYAG laser or TFL laser group for miniPCNL surgery according to standard of care.

TFL laser platform

Device

Patients will be randomly assigned (1:1) to HoYAG or TFL laser group for MiniPCNL surgery according to standard of care.

Primary outcomes

  1. Stone Lithotripsy time between HoYAG and TFL

    Time frame: Procedure

    Time from scope insertion to scope removal

Secondary outcomes

  1. Total operative time between HoYAG and TFL

    Time frame: Procedure

    Time from time-out to procedure finish

  2. Stone Free Status between ClearPetra and traditional approach

    Time frame: 90 days

    Stone free is defined as no residual stones larger than 2mm in post operative CT scan

  3. Laser Energy

    Time frame: Procedure

    Laser efficiency will be measured by evaluating the laser energy in kilojoules used during the procedure.

  4. Laser Time

    Time frame: Procedure

    Laser efficiency will be measured by evaluating the time in minutes the laser was used during the procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Ledesma

CONTACT

[email protected]

913-588-8721

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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