Thulium Fiber Laser Prospective Trial

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

Detailed Description
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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.

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

Conditions
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Kidney Stone

Intervention / Treatment
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* Device: Thulium Fiber Laser


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithotripsy<br>Ureteroscopy with lithotripsy using the Thulium Fiber Laser | Device: Thulium Fiber Laser<br>* Thulium Fiber Laser will be used to break renal stones < 2 cm into fragments small enough to remove or pass spontaneously through the ureter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean total operative time | Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique. | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of stone retropulsion | Review of the procedure video recording to assess stone retropulsion occurence during stone lithotripsy | during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteroscopy, lithotripsy, thulium fiber laser