New Laser and Suction Sheath for Kidney Stone Treatment

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Super Pulsed Thulium Fiber Laser (sTFL) + Flexible Negative Pressure Ureteral Access Sheath (UAS) Intervention
  • Super Pulsed Thulium Fiber Laser (sTFL) + Conventional Ureteral Access Sheath (UAS) Intervention

Treatment groups

140 Participants
are divided into 2 treatment groups

Locations

This trial has no locations