Actively Recruiting
Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-01-21
136
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this prospective, multicenter, randomized controlled trial is to objectively evaluate the clinical efficacy and safety differences between superpulse thulium fiber laser (sTFL) and holmium:YAG laser (Ho:YAG) in flexible ureteroscopy (FURS) lithotripsy in adult patients aged 18-70 years with kidney stones and/or upper ureteral stones (6-20mm). The main questions it aims to answer are: Does sTFL yield a higher stone-free rate (SFR) compared to Ho:YAG at 3 months post-FURS? Is sTFL superior to Ho:YAG in terms of operation time, complication rate, and surgeon's visual experience during FURS? Researchers will compare the experimental group receiving sTFL treatment to the control group receiving Ho:YAG laser treatment to see if sTFL demonstrates better lithotripsy efficiency, safety, and ease of operation. Participants aged 18-70 years will: Undergo FURS lithotripsy under general anesthesia using either sTFL (experimental group) or Ho:YAG laser (control group) based on randomization Have CT scans at 3 months post-operation to assess stone-free status Be monitored for intraoperative and postoperative complications Have surgeons rate their visual experience during the procedure in terms of visual clarity, lithotripsy efficiency, stone movement and tissue injury
CONDITIONS
Official 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
- Diagnosis of kidney stones and/or upper ureteral stones with size between 6 mm and 20 mm
- Planned to undergo flexible ureteroscopy lithotripsy
- Able to have the operation under general anesthesia
- Negative urine culture before surgery
- Signed informed consent confirming understanding and agreement to participate
You will not qualify if you...
- Having only one kidney
- History of kidney transplantation or urinary diversion surgery
- Congenital urinary system malformations
- Abnormal blood clotting due to blood or liver diseases
- Severe heart or lung disease, cancer, or immune deficiency
- Neurogenic bladder
- Unable or unwilling to provide informed consent
- Untreated urinary tract infection
- Known anatomical abnormalities like ureteral stenosis, urothelial tumors, or stones removable without laser
- Pregnancy
- Stones unreachable by bendable suction sheath or conventional sheath
- Surgery under epidural or lumbar anesthesia
- Recurrent stones caused by genetic metabolic diseases
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 201620
Actively Recruiting
Research Team
R
Ruixuan Zhu
CONTACT
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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