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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

136 Participants
are divided into 2 treatment groups