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Laser
Thulium vs. Holmium Lasers for Kidney Stones
N/A
Waitlist Available
Led By Mantu Gupta, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing single stage unilateral RIRS for total stone burden volume >5mm to < 20 mm
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 weeks postoperative
Awards & highlights
Study Summary
This trial compares two laser systems used for kidney stone surgery to see which one is more efficient and effective.
Who is the study for?
This trial is for people with kidney stones between 5mm and 20mm in size, who are scheduled for a specific type of surgery called unilateral RIRS. They must have had a CT scan before the study. People with blood clotting issues, those currently using a ureteral stent, or having certain kidney shapes or urinary tract problems can't participate.Check my eligibility
What is being tested?
The study compares two types of lasers used to break up kidney stones during surgery: the superpulsed thulium fiber laser and the pulse modulated high power holmium laser. Patients will be randomly assigned to one of these treatments to see which is more effective at removing stones.See study design
What are the potential side effects?
Potential side effects from both lasers may include discomfort during urination, bleeding within the urine, possible injury to surrounding tissue in the kidney or ureter, and risks associated with surgical procedures such as infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a procedure for kidney stones larger than 5mm but smaller than 20mm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 weeks postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 weeks postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with stone free status
Secondary outcome measures
Energy utilization
Fragmentation speed
Lasing activity
Trial Design
2Treatment groups
Experimental Treatment
Group I: Thulium Fibre Laser (TFL)Experimental Treatment1 Intervention
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Group II: Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)Experimental Treatment1 Intervention
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thulium Fibre Laser
2022
N/A
~190
Holmium:Yttrium-Aluminum-Garnet
2022
N/A
~190
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,204 Total Patients Enrolled
Mantu Gupta, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a ureteral stent.I have a unique kidney shape or urinary tract issue.You need to have a CT scan before the surgery to take measurements.I have a bladder cancer and my kidney stone removal didn't require a laser but the stone couldn't be reached with a scope.I had a ureteroscopy less than 6 weeks ago.I am having a procedure for kidney stones larger than 5mm but smaller than 20mm.I have a permanent blood clotting disorder.More than half of the kidney stone is made up of uric acid.
Research Study Groups:
This trial has the following groups:- Group 1: Thulium Fibre Laser (TFL)
- Group 2: Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently engaging in the therapeutic trial?
"Affirmative, as evidenced by the clinicaltrials.gov repository, this scientific experiment is currently seeking suitable individuals. The study was initially posted on February 2nd 2023 and has since been updated March 29th of the same year. 82 test subjects are needed from a single location."
Answered by AI
Is there an ongoing recruitment period for this trial?
"Affirmative. Clinicaltrials.gov provides evidence that this research project, which was posted on February 2nd of 2023, is currently recruiting participants. 82 patients need to be secured from one medical facility."
Answered by AI
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