Comparing two laser systems for breaking up kidney stones
Prospective Single-center Study Comparing Thulium Fiber Laser to Pulsed Thulium:YAG Laser in the Ureteroscopic Treatment of Nephrolithiasis
NA · University of California, San Diego · NCT06721975
This study is testing whether a new type of laser for breaking up kidney stones works as well and as quickly as a current laser option during a minimally invasive procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06721975 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of two laser systems, the Thulium Fiber Laser (TFL) and the Thulio Pulsed Thulium:YAG (p-Tm:YAG), in treating kidney stones through ureteroscopy. The study aims to determine if the p-Tm:YAG laser is as effective as TFL in terms of dusting ablation efficiency and speed. Participants will undergo a minimally invasive procedure where the lasers will be used to break up kidney stones, with outcomes measured in a controlled environment. This is the first large-scale study directly comparing these two laser technologies for kidney stone treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals with solitary renal stones measuring 7 to 20 mm who are suitable for flexible ureteroscopy.
Not a fit: Patients with concomitant ureteral stones, prior reconstructive procedures, or certain medical conditions such as pregnancy or untreated urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with kidney stones, potentially enhancing the efficiency and effectiveness of laser lithotripsy.
How similar studies have performed: While there have been pilot studies on the p-Tm:YAG laser, this is the first large-scale comparative trial, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Surgeons participating in the study must be urological attending surgeons or fellows with subspecialty training in Endourology Exclusion Criteria: * 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 * Pregnancy * Untreated UTI
Where this trial is running
San Diego, California
- University of California, San Diego — San Diego, California, United States (RECRUITING)
Study contacts
- Study coordinator: Jade McDermott, BS
- Email: j3mcdermott@health.ucsd.edu
- Phone: 858-777-9721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Stones, Nephrolithiasis, laser lithotripsy, laser, nephrolithiasis, kidney stone