Actively Recruiting
Comparison of Superpulse Thulium Fiber Laser and Holmium:YAG Laser Lithotripsy for Kidney and Upper Ureteral Stones During Flexible Ureteroscopy
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-01-21
136
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the clinical effectiveness and safety of two types of lasers, superpulse thulium fiber laser (sTFL) and holmium:YAG laser (Ho:YAG), used during flexible ureteroscopy (FURS) lithotripsy for adults aged 18 to 70 years with kidney or upper ureteral stones measuring 6-20mm. The study focuses on whether sTFL results in a higher stone-free rate three months after surgery, as well as differences in operation time, complication rates, and the surgeon's visual experience. Participants will be randomly assigned to receive FURS lithotripsy using either the sTFL or Ho:YAG laser under general anesthesia. Experienced urologists will perform all procedures, adjusting laser settings based on the stone characteristics to optimize treatment. The study includes several visits: a baseline screening, intraoperative procedure, postoperative monitoring within 24 hours, and follow-up visits at 3 and 6 months to assess stone clearance and recurrence using CT scans. During the study, participants will undergo CT scans at 3 and 6 months post-operation to check for remaining stones and recurrence. Researchers will monitor vital signs, document any complications using the Clavien-Dindo classification, and evaluate the surgeon's visual experience concerning clarity, efficiency, stone movement, and tissue injury. Adverse events will be recorded throughout the study, which is expected to last until October 2028.
CONDITIONS
Brief Title
Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with kidney stones and/or upper ureteral stones between 6mm and 20mm in size
- Planned to undergo flexible ureteroscopy lithotripsy
- Willing to have the procedure under general anesthesia
- Negative urine culture before surgery
- Provided signed informed consent to participate in the study
You will not qualify if you...
- Having only one kidney
- Previous kidney transplant or urinary diversion surgery
- Congenital malformations of the urinary system
- Abnormal blood clotting due to blood or liver diseases
- Severe heart or lung disease, cancer, or immune deficiency
- Neurogenic bladder condition
- Unable or unwilling to provide informed consent
- Untreated urinary tract infection
- Known urinary tract abnormalities like ureteral stenosis or urothelial tumors
- Stones removable without laser lithotripsy
- Pregnant women
- Stones unreachable with flexible negative pressure suction or conventional sheath
- Surgery performed under epidural or lumbar anesthesia
- Recurrent stones caused by genetic metabolic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 baseline visit (in-person)
Duration - Day of surgery
Participants undergo flexible ureteroscopy with either superpulse thulium fiber laser or holmium:YAG laser for kidney and upper ureteral stone fragmentation. During the procedure, operation time, laser type, surgeon's visual experience, vital signs, and complications are recorded.
1 intraoperative visit (in-person) and monitoring within 24 hours post-surgery
Duration - Up to 6 months after surgery
Participants return for follow-up visits to assess stone clearance and recurrence using CT scans, and to monitor for any complications or adverse events.
2 visits at 3 months and 6 months (in-person)
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 201620
Actively Recruiting
Research Team
R
Ruixuan Zhu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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