SP TLF Versus Ho:YAG Laser

Urinary Calculi Clinical Trial

Official title:

Comparative Effectiveness of the Super Pulse Thulium Fiber Laser (SP TLF) for Laser Lithotripsy of Urinary Calculi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048706
• Other study ID #: STUDY00003725
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: January 2024

Study information

• Verified date: October 2022
• Source: University of Rochester
• Contact: Ahmed Ghazi, MD
• Phone: 585-424-6491
• Email: ahmed_ghazi[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters leading to more efficient (4 times more) and effective stone dusting resulting in production of finer dust particles obviating the need for postoperative ureteric stenting which remains a major source of patient discomfort.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is scheduled to undergo mini-PCNL and/or RIRS surgery at the University of Rochester Medical Center for the management of upper urinary tract calculi (i.e. kidney and proximal ureter)
• Stones located in the kidney and proximal ureter
• Stones measuring 10-30mm
• Ability to give informed consent
• Any racial or ethnic origin
• Age 18 years and older

Exclusion Criteria:

• Active kidney infection
• Patients with prior stenting
• Pregnant patients
• Patients with solitary kidney
• Patients with ureteral tumor or stricture
• Inability to give informed consent
• Not age 18 and older

Related Conditions & MeSH terms

• Calculi
• Urinary Calculi
• Urolithiasis

Intervention

Device:
• Laser lithotripsy (SP TLF)
Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)
• Laser lithotripsy (Ho:YAG)
Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficiency of SP TFL in dusting stones	We plan to assess the direct impact of SP TFL to efficiently dust 10-30mm stones in the upper urinary tract . Metrics include time needed to ablate the stone i.e. ablation speed (stone volume mm3/sec)	6 months
Primary	Mean ablation energy needed to ablate stone volume	We plan to assess the direct impact of SP TFL to effectively dust 10-30mm stones in the upper urinary tract . Metrics include ablation energy needed to ablate the stone volume (Stone volume mm3/Joules)	6 months
Secondary	Number of stones cleared.	We plan to assess the direct impact of SP TFL to produce finer quality dust following disregarding of 10-30mm stones in the upper urinary tract that can spontaneously pass without the need for stenting . Metrics will be stone clearance on postoperative CT scans	9 months
Secondary	Number of participants reporting complications.	We plan to assess the direct impact of SP TFL to safely dust 10-30mm stones in the upper urinary tract . Metrics collected will include review of medical record for the presence of complications (e.g. infection, sepsis, obstruction etc.) for 3 months postoperative related to laser lithotripsy.	9 months