SP TLF Versus Ho:YAG Laser

University of Rochester62 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Urinary Calculi

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Rochester Medical Center

Rochester, New York, United States

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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.

Time frame: 9 months

Data from ClinicalTrials.gov

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