HoYAG vs TFL in miniPCNL With ClearPetra
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
Mini percutaneous nephrolithotripsy is the treatment of choice for kidney stones over 2cm. This procedure commonly uses laser energy for breaking the stones, and among possible laser platforms, Hoyag and thulium fiber laser are FDA approved. Recently, this procedure has also included the use of vacuum assisted renal access sheaths, which allows suction to be employed together with the breaking of stones. This study intends to compare outcomes when using either laser platforms with suction sheaths in participants undergoing mini percutaneous nephrolithotripsy for the treatment of kidney stones.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females over 18 years of age
Patients with kidney stones, with stone burden larger than 15 mm.
Patients undergoing new percutaneous access with primary, supine, unilateral mini-PCNL.
Disqualifiers
Simultaneous use of more than 1 laser platform or other form of fragmentation (e.g., ultrasonic).
Patients undergoing simultaneous treatment of contralateral kidney stones during the same procedure.
Patients undergoing simultaneous treatment of ureteral stones during the same procedure.
Pregnant patients.
Trial design
Design model
Parallel
Treatments tested in this trial
HoYAG laser
DevicePatients will be randomly assigned (1:1) to HoYAG laser or TFL laser group for miniPCNL surgery according to standard of care.
TFL laser platform
DevicePatients will be randomly assigned (1:1) to HoYAG or TFL laser group for MiniPCNL surgery according to standard of care.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: MiniPCNL with HoYAGActive comparator 1 intervention
Group B: MiniPCNL with TFLActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stone Lithotripsy time between HoYAG and TFL
Time from scope insertion to scope removal
Time frame
ProcedureSecondary outcomes
1
Total operative time between HoYAG and TFL
Time from time-out to procedure finish
Time frame
Procedure2
Stone Free Status between ClearPetra and traditional approach
Stone free is defined as no residual stones larger than 2mm in post operative CT scan
Time frame
90 days3
Laser Energy
Laser efficiency will be measured by evaluating the laser energy in kilojoules used during the procedure.
Time frame
Procedure4
Laser Time
Laser efficiency will be measured by evaluating the time in minutes the laser was used during the procedure.
Time frame
ProcedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov