Back to resultsUtilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Primary Purpose
Stone Clearance
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
Sponsored by
About this trial
This is an interventional treatment trial for Stone Clearance
Eligibility Criteria
Inclusion Criteria:
- Subject will be older than 18 years of age
Subject was diagnosed with renal calculi meeting the following criteria:
- Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
- Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
- Subject is a candidate for FURS procedure
- Subject is willing and has signed the Informed Consent Form
Exclusion Criteria:
- Subject has undergone a previous treatment for stones in the same kidney
- Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
- Female subject is pregnant
- Concomitant anticoagulant medication that cannot be suspended during surgery
Sites / Locations
- New York Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stone breaking
Stone dusting
Arm Description
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Outcomes
Primary Outcome Measures
Stone Clearance
stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
Duration of catheterization time
Duration of catheterization will be measured to evaluate treatment efficiency
Procedure time
duration of the procedure as an indicator for treatment efficiency.
Usage of alternative stone extracting devices
The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication.
hospital stay
hospital duration will be measured to evaluate treatment efficiency
Secondary Outcome Measures
Intraoperative Complications
Intraoperative Complications will be evaluated based on Modified Clavien Classification-
Modified Clavien Grading:
Grade 1,Grade 2,Grade 3,Grade 3a,Grade 3b,Grade 4,Grade 4a, Grade 4b, Grade 5.
Visibility during procedure
clear vision of the stone and organ compartments as reflected via endoscope and video screen.
Occurrence of retropulsion that interferes with procedure
The subjective degree of stone movement and migration as a result of the laser treatment that interfere with procedure flow.
Fiber performance
The surgeon will evaluate the degree of Fiber flexibility with scope deflection- and any damage to fiber, Fiber durability- deflection without losing energy/ efficiency and any Damage to scope.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02683993
Brief Title
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Official Title
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumenis Be Ltd.
4. Oversight
5. Study Description
Brief Summary
Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone Clearance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stone breaking
Arm Type
Experimental
Arm Description
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Arm Title
Stone dusting
Arm Type
Experimental
Arm Description
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Intervention Type
Device
Intervention Name(s)
Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
Intervention Description
The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
Primary Outcome Measure Information:
Title
Stone Clearance
Description
stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
Time Frame
Stone clearance based on 1 month follow-up imaging data as compared to baseline
Title
Duration of catheterization time
Description
Duration of catheterization will be measured to evaluate treatment efficiency
Time Frame
Change from 1 month to baseline
Title
Procedure time
Description
duration of the procedure as an indicator for treatment efficiency.
Time Frame
during the procedure
Title
Usage of alternative stone extracting devices
Description
The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication.
Time Frame
as measured during the procedure
Title
hospital stay
Description
hospital duration will be measured to evaluate treatment efficiency
Time Frame
Change from 1 month to baseline
Secondary Outcome Measure Information:
Title
Intraoperative Complications
Description
Intraoperative Complications will be evaluated based on Modified Clavien Classification-
Modified Clavien Grading:
Grade 1,Grade 2,Grade 3,Grade 3a,Grade 3b,Grade 4,Grade 4a, Grade 4b, Grade 5.
Time Frame
during the procedure and during 1 month follow up
Title
Visibility during procedure
Description
clear vision of the stone and organ compartments as reflected via endoscope and video screen.
Time Frame
during the procedure
Title
Occurrence of retropulsion that interferes with procedure
Description
The subjective degree of stone movement and migration as a result of the laser treatment that interfere with procedure flow.
Time Frame
during the procedure
Title
Fiber performance
Description
The surgeon will evaluate the degree of Fiber flexibility with scope deflection- and any damage to fiber, Fiber durability- deflection without losing energy/ efficiency and any Damage to scope.
Time Frame
during the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject will be older than 18 years of age
Subject was diagnosed with renal calculi meeting the following criteria:
Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
Subject is a candidate for FURS procedure
Subject is willing and has signed the Informed Consent Form
Exclusion Criteria:
Subject has undergone a previous treatment for stones in the same kidney
Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
Female subject is pregnant
Concomitant anticoagulant medication that cannot be suspended during surgery
Facility Information:
Facility Name
New York Methodist Hospital
City
New York
State/Province
New York
ZIP/Postal Code
11215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
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