New Laser and Suction Sheath for Kidney Stone Treatment

Launched by YI SHAO · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for kidney stones using a special laser called the super pulsed thulium fiber laser (sTFL) combined with a flexible suction device. Researchers want to find out if this new combination works better and is safer than the traditional method, which uses a standard suction sheath. The main goals are to see if patients using the new device have fewer stones remaining after treatment and experience fewer complications.

To participate in this trial, you need to be at least 18 years old and have kidney stones that are between 6mm and 20mm in size. If you join, you will undergo a procedure where a thin tube called a ureteroscope is used to reach the stone. In the experimental group, the doctors will use the new suction device to help remove the stone fragments, while the control group will use the regular method. It’s important to know that this trial is not yet recruiting participants, and there are certain health conditions that may prevent someone from joining, like severe heart or lung disease or a history of kidney transplantation. If you are interested or think you might be eligible, you can discuss this with your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years old.
• • Diagnosed with kidney stones and/or ureteral stones, and stone diameter is ≥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
• 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
• • Epidural anesthesia or lumbar anesthesia to complete the operation