Thulium Fiber Laser Prospective Trial

Not Applicable

Recruiting

• Conditions: Kidney Stone
• Interventions: Device: Thulium Fiber Laser

• Registration Number: NCT05814133
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-14
• Status Verified: 2024-01
• Study Start: 2024-01-15
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Primary Completion: 2025-01-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lithotripsy	Thulium Fiber Laser	Ureteroscopy with lithotripsy using the Thulium Fiber Laser

Primary Outcome Measures

Name	Time	Method
Mean total operative time	during the procedure	Total operative time during the ureteroscopic treatment of renal stones using a laser dusting technique.

Secondary Outcome Measures

Name	Time	Method
Rate of stone retropulsion	during the procedure	Review of the procedure video recording to assess stone retropulsion occurence during stone lithotripsy

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada