Thulium Fiber Laser Prospective Trial

Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis

This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.

Flexible ureteroscopy is considered the first-line therapy for renal stones < 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.

Inclusion Criteria:

• Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter of 8-20 mm is required
• Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
• Must be 18 years or older
• Must be able to give consent
• Bilateral ureteroscopy will be permitted but only the first side will be included in the study

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 Urinary Tract Infection (UTI)