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/34902273Actively Recruiting
Led by University of Kansas Medical Center · Updated on 2026-05-06
150
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of Kansas Medical Center
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
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
HoYAG vs TFL in miniPCNL With ClearPetra
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
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
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
J
Jane Ledesma
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Pei Li, Ziye Huang, Xia Sun...
https://pubmed.ncbi.nlm.nih.gov/34902273Yang Liu, Wei Zhu, Guohua Zeng
https://pubmed.ncbi.nlm.nih.gov/33470685Olivier Traxer, Etienne Xavier Keller
https://pubmed.ncbi.nlm.nih.gov/30729311