Recruiting

Hoyag vs. Thulium

Sponsor:

University of Kansas Medical Center

Code:

NCT07087977

Conditions

Nephrolithiasis

Kidney Stone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HoYAG laser

TFL laser platform

Study Details

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.

Conditions

Nephrolithiasis

Kidney Stone

Study ID

NCT07087977

Start date

Aug 22, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: MiniPCNL with HoYAG

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

active comparator: MiniPCNL with TFL

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

Interventions

HoYAG laser

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

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

Primary outcome measure

  • Stone Lithotripsy time between HoYAG and TFL [ Time Frame: Procedure ]

Central Contacts and Locations

Central contacts

Jane Ledesma

913-588-8721jledesma2@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Jane Ledesma

913-588-8721jledesma2@kumc.edu

Principal Investigator:

Bristol Whiles, MD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Nephrolithiasis
  • Kidney Stone
  • ClearPetra
  • HoYAG
  • TFL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-06.