Comparing two types of lasers for treating kidney stones
Comparing the Efficacy of Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease: a Randomized Controlled Trial
This study is testing whether a new type of laser treatment for kidney stones works better and is safer than the standard laser treatment for people with larger stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06306222 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial designed to compare the efficacy and safety of Thulium fiber laser (TFL) versus holmium:yttrium-aluminum-garnet (Ho:YAG) laser for the treatment of upper urinary tract stone disease using flexible ureteroscopy. The study aims to demonstrate the clinical superiority of TFL in treating renal and ureteral stones larger than 4 mm. Participants will be randomly assigned to receive one of the two laser treatments, and outcomes will be measured to assess effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with renal or ureteral stones larger than 4 mm.
Not a fit: Patients with anatomical abnormalities that affect the urinary tract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from urinary stone disease.
How similar studies have performed: Other studies have shown varying degrees of success with laser treatments for urinary stones, but this specific comparison of TFL and Ho:YAG is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Renal/ureteral stones \> 4 mm Exclusion Criteria: * Anatomical abnormalities
Where this trial is running
Milan
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: D'Arma Alessia
- Email: darma.alessia@hsr.it
- Phone: +390226435506
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.