Clinical Research Directory

New Laser and Suction Sheath for Kidney Stone Treatment

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Summary

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.

Official title: 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

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