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

Launched by YI SHAO · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different types of lasers used to break up kidney stones during a procedure called flexible ureteroscopy (FURS). The main goal is to find out if the superpulse thulium fiber laser (sTFL) is more effective and safer than the traditional holmium:YAG laser (Ho:YAG). Researchers will look at how well each laser removes stones, how long the procedure takes, any complications that might arise, and how the surgeon feels about the visibility and ease of the procedure.

To participate in this trial, individuals must be between 18 and 70 years old and have kidney stones or upper ureteral stones that are between 6mm and 20mm in size. They must also be able to undergo the procedure under general anesthesia and have a recent negative urine culture. Participants will receive either the sTFL or Ho:YAG laser treatment and will have a CT scan three months later to check if the stones are gone. Throughout the process, their experiences will be monitored to ensure safety and effectiveness. This trial is not yet open for recruitment.

Gender

ALL

Eligibility criteria

• 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