Thulium Fiber Laser Prospective Trial (TFL)

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Enrolling

Conditions

Kidney Stone

Treatments

Device: Thulium Fiber Laser

Study type

Interventional

Funder types

Other

Identifiers

NCT05814133

2023-11370

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)