Comparison of Super Pulse Fiber Thulium Laser and Holmium Laser Lithotripsy Under Ureteroscopy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai General Hospital
RECRUITING
Shanghai
Contact Information
Primary
Ruixuan Zhu
luluzhu2023@qq.com
+86 13780820139
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2028-10-20
Participants
Target number of participants: 136
Treatments
sTFL Group
Kidney stones and/or upper ureteral stones are treated with a superpulsed thulium fiber laser (sTFL)
Ho:YAG Group
Kidney stones and/or upper ureteral stones are treated with a holmium :YAG laser (Ho:YAG)
Sponsors
Leads: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov

Similar Clinical Trials