RecruitingNot Applicable

Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy

China136 participantsStarted 2025-01-20

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years old * Diagnosis of kidney stones and/or upper ureteral stones with stone diameter ≥6mm and ≤20mm * Plan to undergo fURS lithotripsy * General anesthesia to complete the operation * The latest urine culture before surgery is negative * Signed and dated informed consent indicating that the patient or his or her legal representative has been fully informed about the study and has consented to participate Exclusion Criteria: * Isolated kidney * Previous history of kidney transplantation or urinary diversion surgery * Congenital malformations of urinary system * Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc. * Severe heart or lung disease, malignancy and immune deficiency status * Neurogenic bladder * Failure to provide informed consent * Have an untreated urinary tract infection * The presence of known anatomic abnormalities (such as ureteral stenosis), urothelial tumors, or stones that can be removed directly without the use of laser lithotripsy * Pregnant women * In cases where the stone cannot be reached with a bendable negative pressure suction sheath, or in cases where the stone cannot be reached with a conventional sheath or the pyeloureteral junction * Surgical completion under epidural anesthesia or lumbar anesthesia * Recurrent stones due to genetic metabolic diseases

What they're measuring

Stone-free Rate

Timeframe: 3 months post-procedure

Trial details

NCT IDNCT06667557

SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10-20

Contact for this trial

Ruixuan Zhu

+86 13780820139 luluzhu2023@qq.com