Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683993
Recruitment Status : Unknown
Verified January 2017 by Lumenis Ltd..
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date August 29, 2017
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • Stone Clearance [ Time Frame: Stone clearance based on 1 month follow-up imaging data as compared to baseline ]
    stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
  • Duration of catheterization time [ Time Frame: Change from 1 month to baseline ]
    Duration of catheterization will be measured to evaluate treatment efficiency
  • Procedure time [ Time Frame: during the procedure ]
    duration of the procedure as an indicator for treatment efficiency.
  • Usage of alternative stone extracting devices [ Time Frame: as measured during the procedure ]
    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 [ Time Frame: Change from 1 month to baseline ]
    hospital duration will be measured to evaluate treatment efficiency
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • Intraoperative Complications [ Time Frame: during the procedure and during 1 month follow up ]
    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 [ Time Frame: during the procedure ]
    clear vision of the stone and organ compartments as reflected via endoscope and video screen.
  • Occurrence of retropulsion that interferes with procedure [ Time Frame: during the procedure ]
    The subjective degree of stone movement and migration as a result of the laser treatment that interfere with procedure flow.
  • Fiber performance [ Time Frame: during the procedure ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Official Title  ICMJE Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stone Clearance
Intervention  ICMJE Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
Study Arms  ICMJE
  • Experimental: Stone breaking
    Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
    Intervention: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
  • Experimental: Stone dusting
    Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
    Intervention: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject will be older than 18 years of age
  2. 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.
  3. Subject is a candidate for FURS procedure
  4. Subject is willing and has signed the Informed Consent Form

Exclusion Criteria:

  1. Subject has undergone a previous treatment for stones in the same kidney
  2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
  3. Female subject is pregnant
  4. Concomitant anticoagulant medication that cannot be suspended during surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683993
Other Study ID Numbers  ICMJE LUM-SBU-VP-15-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lumenis Ltd.
Study Sponsor  ICMJE Lumenis Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lumenis Ltd.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP