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
This trial does not accept healthy volunteersQualifiers
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 population
Patients aged 18-70 years who plan to undergo ureteral soft endoscopic (fURS) lithotripsy for kidney stones and/or ureteral stones (6-20mm)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Super Pulsed Thulium Fiber Laser (sTFL) + Flexible Negative Pressure Ureteral Access Sheath (UAS) Intervention
DeviceThe 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.
Super Pulsed Thulium Fiber Laser (sTFL) + Conventional Ureteral Access Sheath (UAS) Intervention
DeviceThe 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: sTFL + Flexible Negative-Pressure UAS1 intervention
Group B: sTFL + Conventional UAS1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months postoperativelySecondary outcomes
1
time of operation
The incidence of intraoperative and postoperative complications including infection, bleeding, and instrument - related injuries. This helps to evaluate the safety of the two treatment methods
Time frame
During the surgical procedure2
Complication
The incidence of intraoperative and postoperative complications including infection, bleeding, and instrument - related injuries. This helps to evaluate the safety of the two treatment methods.
Time frame
During the surgical procedure and within 24 hours after the surgical procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: