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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.

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.

Condition or disease Intervention/treatment Phase
Stone Clearance Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Study Start Date : February 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones
Drug Information available for: Holmium

Arm Intervention/treatment
Experimental: Stone breaking
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
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.

Experimental: Stone dusting
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
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.




Primary Outcome Measures :
  1. 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.

  2. Duration of catheterization time [ Time Frame: Change from 1 month to baseline ]
    Duration of catheterization will be measured to evaluate treatment efficiency

  3. Procedure time [ Time Frame: during the procedure ]
    duration of the procedure as an indicator for treatment efficiency.

  4. 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.

  5. hospital stay [ Time Frame: Change from 1 month to baseline ]
    hospital duration will be measured to evaluate treatment efficiency


Secondary Outcome Measures :
  1. 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.


  2. Visibility during procedure [ Time Frame: during the procedure ]
    clear vision of the stone and organ compartments as reflected via endoscope and video screen.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683993


Locations
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United States, New York
New York Methodist Hospital
New York, New York, United States, 11215
Sponsors and Collaborators
Lumenis Ltd.
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Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT02683993    
Other Study ID Numbers: LUM-SBU-VP-15-01
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Calculi
Pathological Conditions, Anatomical