SP TLF Versus Ho:YAG Laser

Not Applicable

Completed

• Conditions: Urinary Calculi
• Interventions: Device: Laser lithotripsy (SP TLF)

• Registration Number: NCT05048706
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-17
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Super Pulse Thulium fiber Laser	Laser lithotripsy (SP TLF)	-

Primary Outcome Measures

Name	Time	Method
To determine the efficiency of SP TFL in dusting stones	6 months	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)
Mean ablation energy needed to ablate stone volume	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Number of stones cleared.	9 months	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
Number of participants reporting complications.	9 months	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.

Trial Locations

Locations (2)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

University of Rochester; 🇺🇸 Rochester, New York, United States