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Completed

NCT Number: NCT05048706

SP TLF Versus Ho:YAG Laser

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.

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Key information

Conditions

Urinary Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester, Rochester, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser lithotripsy (SP TLF)

Device

Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)

Laser lithotripsy (Ho:YAG)

Device

Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.

Primary outcomes

  1. To determine the efficiency of SP TFL in dusting stones

    Time frame: 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)

  2. Mean ablation energy needed to ablate stone volume

    Time frame: 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 outcomes

  1. Number of stones cleared.

    Time frame: 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

  2. Number of participants reporting complications.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 17, 2021
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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