SP TLF Versus Ho:YAG Laser

NCT ID: NCT05048706

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2024-01-01

Brief Summary

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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

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Conditions

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Urinary Calculi

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Super Pulse Thulium fiber Laser

Laser lithotripsy (SP TLF)

Intervention Type DEVICE

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

Holmium: Yttrium-Aluminium-Garnet Laser

Laser lithotripsy (Ho:YAG)

Intervention Type DEVICE

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

Interventions

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Laser lithotripsy (SP TLF)

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

Intervention Type DEVICE

Laser lithotripsy (Ho:YAG)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Ghazi, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00005201

Identifier Type: -

Identifier Source: org_study_id

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