Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser lithotripsy for kidney stone treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 7-20 mm is required
Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines
Must be able to give consent
Bilateral ureteroscopy will be permitted but only the first side (per surgeon discretion) will be included in the study
Disqualifiers
Concomitant stones in the ureter
Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
Prior radiotherapy to the abdomen or pelvis
Neurogenic bladder or spinal cord injury
Trial design
Design model
Parallel
Treatments tested in this trial
Thulio pulsed Thulium:YAG (p-Tm:YAG)
DeviceA new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG ) is beginning to be studied in vitro and in vivo. Dornier Thulio p-Tm:YAG may represent an attractive new laser platform, with comparable properties to TFL including decreased retropulsion, smaller dust, and improved ablation efficiency relative to Ho:YAG.
Thulium Laser Fiber (TFL)
DeviceThe thulium fiber laser (TFL) has demonstrated effectiveness in this procedure
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: p-Tm:YAG laser systemExperimental treatment 1 intervention
Group B: TFL laser systemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The amount of energy used per given stone volume
The primary object is to assess the stone dusting ablation efficiency - efficiency will be defined by amount of laser energy used per stone volume (Joules/mm3)
Time frame
From enrollment to the follow up imaging at 6-12 weeksSecondary outcomes
1
Laser ablation speed (volume of stone/lasing time = mm3/sec)
Secondary objectives include assessing stone dusting ablation speed. This is assessed by taking the stone volume ablated (mm3) and dividing it by lasing time (seconds) - mm3/sec.
Time frame
From enrollment to the follow up imaging at 6-12 weeks2
Post-operative complications compared between the two laser systems
Secondary objectives include assessing post-operative complications. This is defined as the proportion of post-operative infections, readmissions to the hospital, and unplanned procedures compared between the two laser systems.
Time frame
From enrollment to the follow up imaging at 6-12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
Dornier MedTech Systems
Collaborator
Source ClinicalTrials.gov