HoYAG vs TFL in miniPCNL With ClearPetra

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT07087977
Status
Recruiting
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Conditions

  • Kidney Stone
  • Nephrolithiasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 22, 2025
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Jane Ledesma
[email protected]
913-588-8721
Bristol Whiles, MD (PRINCIPAL_INVESTIGATOR)

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University of Kansas Medical Center· Kansas City, KS

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