SP TLF Versus Ho:YAG Laser

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Calculi
• Intervention / Treatment: Device: Laser lithotripsy (SP TLF); Device: Laser lithotripsy (Ho:YAG)

• Study Type: Observational
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects eligible for this study will be identified via eRecord in the Urology Department (routine access) of patients who were diagnosed with upper urinary tract calculi who underwent surgery utilizing either high powered Ho:YAG or TL-SPL lasers.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Super Pulse Thulium fiber Laser	Device: Laser lithotripsy (SP TLF); Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)
Holmium: Yttrium-Aluminium-Garnet Laser	Device: Laser lithotripsy (Ho:YAG); Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Ahmed Ghazi, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Calculi; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: STUDY00005201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No