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โ† Trials
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Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy

Recruitingn/aAges 18 Years - 70 YearsAllShanghai General Hospital, Shanghai Jiao Tong Uniโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 genera

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years old * Diagnosis of kidney stones and/or upper ureteral stones with stone diameter โ‰ฅ6mm and โ‰ค20mm * 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
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What it tests

  • Superpulse Thulium Fiber Laser (sTFL) Treatment
  • Holmium:YAG Laser (Ho:YAG) Treatment
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Where

1 site
Shanghai General Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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