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Laser Therapy
Laser Systems for Kidney Stones
N/A
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 7-20 mm is required
Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines
Must not have
Neurogenic bladder or spinal cord injury
Concomitant stones in the ureter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the follow up imaging at 6-12 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing two laser systems to see how well they can break up kidney stones during a procedure called ureteroscopy with laser lithotripsy for kidney stone treatment."
Who is the study for?
This trial is for individuals with kidney stones who can consent to treatment and are good candidates for a specific type of surgery called flexible ureteroscopy. Surgeons involved must be specialized in Endourology. Participants should have a single kidney stone or multiple stones totaling 7-20 mm in size, but those with certain urinary conditions, pregnancy, untreated UTI, other stones, prior surgeries or radiotherapy to the area cannot join.
What is being tested?
The study compares two laser systems used during ureteroscopy: Thulium Fiber Laser (TFL) and pulsed Thulium:YAG (p-Tm:YAG). It aims to determine which system is more effective at breaking up kidney stones during this minimally invasive procedure.
What are the potential side effects?
While not explicitly stated here, typical side effects from such procedures may include discomfort at the site of surgery, bleeding, potential infection risk post-operation and temporary issues with urination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a kidney stone or stones measuring 7 to 20 mm in total.
Select...
I am considered fit for a specific kidney stone removal surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a bladder condition due to nerve problems or a spinal cord injury.
Select...
I have stones in my ureter.
Select...
I have had surgery on the urinary tract or a narrow ureter on one side before.
Select...
I have had radiation therapy to my abdomen or pelvis.
Select...
I currently have a urinary tract infection that hasn't been treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to the follow up imaging at 6-12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the follow up imaging at 6-12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The amount of energy used per given stone volume
Secondary study objectives
Laser ablation speed (volume of stone/lasing time = mm3/sec)
Post-operative complications compared between the two laser systems
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: p-Tm:YAG laser systemExperimental Treatment1 Intervention
This is a new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG)
Group II: TFL laser systemActive Control1 Intervention
The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure.
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,823 Total Patients Enrolled
Dornier MedTech SystemsIndustry Sponsor
4 Previous Clinical Trials
291 Total Patients Enrolled