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SP TLF Versus Ho:YAG Laser

Primary Purpose

Urinary Calculi

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser lithotripsy (SP TLF)
Laser lithotripsy (Ho:YAG)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Calculi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester Medical Center
  • University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Super Pulse Thulium fiber Laser

Holmium: Yttrium-Aluminium-Garnet Laser

Arm Description

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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
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.

Full Information

First Posted
September 8, 2021
Last Updated
October 6, 2022
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT05048706
Brief Title
SP TLF Versus Ho:YAG Laser
Official Title
Comparative Effectiveness of the Super Pulse Thulium Fiber Laser (SP TLF) for Laser Lithotripsy of Urinary Calculi
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Super Pulse Thulium fiber Laser
Arm Type
Experimental
Arm Title
Holmium: Yttrium-Aluminium-Garnet Laser
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Laser lithotripsy (SP TLF)
Intervention Description
Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)
Intervention Type
Device
Intervention Name(s)
Laser lithotripsy (Ho:YAG)
Intervention Description
Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.
Primary Outcome Measure Information:
Title
To determine the efficiency of SP TFL in dusting stones
Description
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
Title
Mean ablation energy needed to ablate stone volume
Description
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 Outcome Measure Information:
Title
Number of stones cleared.
Description
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
Title
Number of participants reporting complications.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ghazi, MD
Phone
585-424-6491
Email
ahmed_ghazi@urmc.rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tyler Holler, MPH
Phone
585-276-3063
Email
tyler_holler@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Ghazi, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Ghazi, MD
Phone
585-424-6491
Email
ahmed_ghazi@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Tyler Holler, MPH
Phone
585-276-3063
Email
tyler_holler@urmc.rochester.edu
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Ghazi, MD
First Name & Middle Initial & Last Name & Degree
Rajat Jain, MD
First Name & Middle Initial & Last Name & Degree
Scott Quarrier, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other researchers.

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SP TLF Versus Ho:YAG Laser

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