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Prospective, Multicenter, Randomized Controlled Trial of Super Pulse Thulium Fiber Laser Combined With Flexible Negative Pressure Suction Sheath Versus Conventional Sheath for the Treatment of Kidney Stones
Sponsor study identifier
observational
140
0 countries
N/A
Study Start
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2024
Actual (reported)October 31, 2024
Actual (reported)November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Stone free rate
The proportion of patients with no residual stone or with residual stone diameter less than 2mm, as determined by non - contrast CT scan. This measure is used to evaluate the effectiveness of the two treatment methods in completely removing the stones.
3 months postoperatively
time of operation
During the surgical procedure
Complication
During the surgical procedure and within 24 hours after the surgical procedure
Under general anesthesia, a guidewire is first inserted. Then, the Flexible Negative Pressure UAS is inserted along the guidewire to the stone site. A ureteroscope is inserted through the sheath to the stone site. The sTFL is used to fragment the stone with a power setting of 0.8J and a frequency of 12 - 20Hz. Simultaneously, the fragmented stones are removed by negative pressure suction.
Under general anesthesia, the Conventional UAS is inserted to the upper ureter or the ureteropelvic junction. A ureteroscope is inserted through the sheath to the stone site. The sTFT is used to fragment the stone with a power setting of 0.8J and a frequency of 12 - 20Hz. After fragmentation, the stones are removed by a stone basket.
The intervention combines a Super Pulsed Thulium Fiber Laser (sTFL) with a power setting of 0.8J and a frequency of 12 - 20Hz for stone fragmentation and a Flexible Negative Pressure Ureteral Access Sheath (UAS) that allows access to the stone site and enables negative pressure suction for stone removal.
Patients aged 18-70 years who plan to undergo ureteral soft endoscopic (fURS) lithotripsy for kidney stones and/or ureteral stones (6-20mm)
Yi Shao
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First Submitted
October 30, 2024
First Posted
October 31, 2024
Study Start
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 20, 2026
The intervention combines a Super Pulsed Thulium Fiber Laser (sTFL) with a power setting of 0.8J and a frequency of 12 - 20Hz for stone fragmentation and a Conventional Ureteral Access Sheath (UAS) used for access to the upper ureter or ureteropelvic junction for stone treatment.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 21, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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