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Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy

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: NCT02279927
Recruitment Status : Unknown
Verified October 2014 by Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center

Brief Summary:
A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy

Condition or disease Intervention/treatment Phase
Ureterolithiasis Nephrolithiasis Device: Ureteroscopy Not Applicable

Detailed Description:
Two groups prospectively randomized for different laser settings during ureteroscopy one aimed for stone dusting, the other for stone fragmentation and basket extraction of fragments

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During
Study Start Date : October 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Experimental: Low energy high frequency
Ureteroscopy with laser settings of low energy & high frequency with aim of stone dusting
Device: Ureteroscopy
Ureteroscopy with laser stone fragmentation

Active Comparator: High energy low frequency
Ureteroscopy with laser settings of low energy high frequency with aim of stone fragmentation and basket extraction of fragments
Device: Ureteroscopy
Ureteroscopy with laser stone fragmentation




Primary Outcome Measures :
  1. Stone free rate [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Duration of operation [ Time Frame: Immediate ]


Information from the National Library of Medicine

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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:

  • Patients who are planned for ureteroscopy \ retrograde intra renal surgery (RIRS) for stone treatment

Exclusion Criteria:

  • known ureteral stricture
  • severe immune deficiency
  • patients after urinary diversion surgery
  • patients with single \ ectopic\ implanted kidney
  • double collecting system
  • severe thrombocytopenia
  • patients taking anticoagulant drugs that cannot be stooped before the operation

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): NCT02279927


Contacts
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Contact: Yuval Freifeld +97248250843 yuvalfr@clalit.org.il

Locations
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Israel
Carmel Medical Center Recruiting
Haifa, Israel
Contact: Yuval Freifeld    +97248250843    yuvalfr@clalit.org.il   
Principal Investigator: Yuval Freifeld, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Yuval Freifeld Carmel MC

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Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02279927    
Other Study ID Numbers: CMC-14-0063-CTIL
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by Carmel Medical Center:
Ureteroscopy
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Ureterolithiasis
Ureteral Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Ureteral Diseases