New Laser and Suction Sheath for Kidney Stone Treatment
Starting soon
Conditions studied: Kidney Calculi, Ureteral Calculi
In brief
The goal of this clinical trial is to learn if the combination of super pulsed thulium fiber laser (sTFL) with a flexible negative pressure suction sheath is more effective and safer than sTFL with a conventional sheath in treating kidney stones and/or ureteral stones. The main questions it aims to answer are: Does the sTFL with a flexible negative pressure suction sheath have a higher stone - free rate than the sTFL with a conventional sheath? Does the sTFL with a flexible negative pressure suction sheath have fewer complications than the sTFL with a conventional sheath? Researchers will compare the two treatment groups to see if there are differences in stone - free rate and complication rates. Participants will: Undergo ureteroscopic lithotripsy surgery. In the experimental group, have a flexible negative pressure suction sheath inserted along a guidewire to the stone site under general anesthesia, then have a ureteroscope inserted through the sheath to the stone site, and have the stone fragmented by sTFL with a power setting of 0.8J and a frequency of 12 - 20Hz while the fragments are removed by negative pressure suction. In the control group, have a conventional sheath inserted to the upper ureter or the ureteropelvic junction under general anesthesia, then have a ureteroscope inserted through the sheath to the stone site, and have the stone fragmented by sTFL with a power setting of 0.8J and a frequency of 12 - 20Hz and the fragments removed by a stone basket.
Key facts
- Study ID
- NCT06667466
- Run by
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- People needed
- 140
- Starts
- 2026-11-20
- Expected to finish
- 2027-11-20
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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