HoYAG vs TFL in miniPCNL With ClearPetra

NCT07087977 | Recruiting FDA Device

• 1 other identifier: STUDY00161413
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Nephrolithiasis; Kidney Stone; ClearPetra; HoYAG; TFL

Outcome Measures

Primary Outcomes (1)

• Stone Lithotripsy time between HoYAG and TFL

  Time from scope insertion to scope removal

  Procedure

Secondary Outcomes (4)

• Total operative time between HoYAG and TFL

  Procedure

• Stone Free Status between ClearPetra and traditional approach

  90 days

• Laser Energy

  Procedure

• Laser Time

  Procedure

Study Arms (2)

MiniPCNL with HoYAG

ACTIVE COMPARATOR

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

Device: HoYAG laser

MiniPCNL with TFL

ACTIVE COMPARATOR

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

Device: TFL laser platform

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.

MiniPCNL with HoYAG

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.

MiniPCNL with TFL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (3)

• Li P, Huang Z, Sun X, Yang T, Wang G, Jiang Y, Ke C, Li J. Comparison of Vacuum Suction Sheath and Non-Vacuum Suction Sheath in Minimally Invasive Percutaneous Nephrolithotomy: A Meta-Analysis. J Invest Surg. 2022 May;35(5):1145-1152. doi: 10.1080/08941939.2021.1995538. Epub 2021 Dec 13.

  PMID: 34902273 BACKGROUND

• Liu Y, Zhu W, Zeng G. Percutaneous nephrolithotomy with suction: is this the future? Curr Opin Urol. 2021 Mar 1;31(2):95-101. doi: 10.1097/MOU.0000000000000854.

  PMID: 33470685 BACKGROUND

• Traxer O, Keller EX. Thulium fiber laser: the new player for kidney stone treatment? A comparison with Holmium:YAG laser. World J Urol. 2020 Aug;38(8):1883-1894. doi: 10.1007/s00345-019-02654-5. Epub 2019 Feb 6.

  PMID: 30729311 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol Whiles, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Ledesma

CONTACT

913-588-8721; jledesma2@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Model Details: Parallel assignment

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 28, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)