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Laser Lithotripter
SP TLF vs Ho:YAG Laser for Kidney Stones
N/A
Recruiting
Led By Ahmed Ghazi, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial will compare the performance of two different lasers for treating kidney stones. The investigators think that the electronically-modulated laser diodes of the TFL offers more efficient and effective stone dusting, resulting in production of finer dust particles. This may obviate the need for postoperative ureteric stenting, which remains a major source of patient discomfort.
Who is the study for?
This trial is for adults over 18 who need mini-PCNL or RIRS surgery at the University of Rochester Medical Center to remove kidney stones located in the kidney and proximal ureter, measuring 10-30mm. It's not for pregnant individuals, those unable to consent, under 18s, patients with active kidney infections, prior stenting, a solitary kidney or ureteral tumors/strictures.Check my eligibility
What is being tested?
The study compares two types of laser lithotripsy: Super Pulse Thulium fiber laser (SP TLF) and standard Holmium: YAG (Ho:YAG). The goal is to see if SP TLF can produce finer stone dust more efficiently than Ho:YAG which could eliminate the need for postoperative stents that cause discomfort.See study design
What are the potential side effects?
Potential side effects from both laser treatments may include pain during urination, bleeding around the treated area, possible infection risk due to fragments removal process and discomfort associated with any inserted surgical tools.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean ablation energy needed to ablate stone volume
To determine the efficiency of SP TFL in dusting stones
Secondary outcome measures
Number of participants reporting complications.
Number of stones cleared.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Super Pulse Thulium fiber LaserExperimental Treatment1 Intervention
Group II: Holmium: Yttrium-Aluminium-Garnet LaserActive Control1 Intervention
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Who is running the clinical trial?
University of RochesterLead Sponsor
845 Previous Clinical Trials
534,917 Total Patients Enrolled
1 Trials studying Kidney Stones
Ahmed Ghazi, MDPrincipal InvestigatorAssociate Professor
3 Previous Clinical Trials
176 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a kidney infection.You have only one kidney.You have kidney or ureter stones.Kidney stones between 10 and 30 millimeters in size.You have had a stent placed in the past.You have a tumor or blockage in your ureter.You are planning to have a specific type of surgery for kidney or upper ureter stones at the University of Rochester Medical Center.
Research Study Groups:
This trial has the following groups:- Group 1: Super Pulse Thulium fiber Laser
- Group 2: Holmium: Yttrium-Aluminium-Garnet Laser
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.
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