NCT05814133

Thulium Fiber Laser Prospective Trial

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Kidney Stone

Interventions

Type	Name	Description
DEVICE	Thulium Fiber Laser	Thulium Fiber Laser will be used to break renal stones \< 2 cm into fragments small enough to remove or pass spontaneously through the ureter.

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-01-15
• Completion: 2025-07-15
• First posted: 2023-04-14
• Last updated: 2024-01-31

Locations

1 site across 1 country: Canada