Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07087977

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

Led by University of Kansas Medical Center · Updated on 2026-05-06

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Kansas Medical Center

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the treatment of kidney stones larger than 2cm using a procedure called mini percutaneous nephrolithotripsy (miniPCNL). This procedure commonly uses laser energy to break stones, and the study compares two FDA-approved laser platforms: Holmium:YAG (HoYAG) laser with MOSES technology and the thulium fiber laser (TFL). The study aims to evaluate which laser platform provides better outcomes when combined with a new vacuum-assisted renal access sheath called ClearPetra™, which allows suction during stone breaking. Participants will be randomly assigned to one of two groups. One group will have miniPCNL using the ClearPetra™ sheath with the HoYAG laser, while the other group will use the same sheath with the TFL laser. Both groups will undergo the miniPCNL procedure according to standard care practices. The study specifically investigates differences in stone fragmentation efficiency and surgical outcomes between these two laser technologies. During the study, participants will undergo assessments including measurement of stone lithotripsy time, total operative time, laser energy used, and laser time during the procedure. Stone-free status will also be checked 90 days after surgery. The study is conducted by the University of Kansas Medical Center and will follow participants from the start of the procedure through follow-up visits to monitor outcomes and safety throughout the trial period ending in 2027.

CONDITIONS

Brief Title

HoYAG vs TFL in miniPCNL With ClearPetra

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females over 18 years of age
  • Patients with kidney stones larger than 15 mm
  • Patients undergoing new percutaneous access with primary, supine, unilateral mini-PCNL
Not Eligible

You will not qualify if you...

  • Use of more than one laser platform or other fragmentation methods during the procedure
  • Simultaneous treatment of stones in the opposite kidney during the same procedure
  • Simultaneous treatment of ureteral stones during the same procedure
  • Pregnancy
  • Presence of genitourinary anatomical abnormalities
  • Uncorrected bleeding disorders
  • Use of external urinary catheters
  • Immunosuppression
  • Non-elective procedures

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate post-operative period

Participants undergo mini-percutaneous nephrolithotomy (miniPCNL) surgery using either the HoYAG laser with MOSES technology or the Thulium Fiber Laser (TFL) with the ClearPetra™ vacuum-assisted renal access sheath as part of the procedure.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 90 days

Participants are followed up to assess stone clearance and recovery after the miniPCNL procedure.

1 to 2 follow-up visits

Trial Site Locations

Total: 1 location

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

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Research Team

J

Jane Ledesma

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Comparison of Vacuum Suction Sheath and Non-Vacuum Suction Sheath in Minimally Invasive Percutaneous Nephrolithotomy: A Meta-Analysis.

Pei Li, Ziye Huang, Xia Sun...

https://pubmed.ncbi.nlm.nih.gov/34902273