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

Primary Purpose

Ureterolithiasis, Nephrolithiasis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ureteroscopy
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureterolithiasis focused on measuring Ureteroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low energy high frequency

High energy low frequency

Arm Description

Ureteroscopy with laser settings of low energy & high frequency with aim of stone dusting

Ureteroscopy with laser settings of low energy high frequency with aim of stone fragmentation and basket extraction of fragments

Outcomes

Primary Outcome Measures

Stone free rate

Secondary Outcome Measures

Duration of operation

Full Information

First Posted
October 29, 2014
Last Updated
October 29, 2014
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02279927
Brief Title
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy
Official Title
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureterolithiasis, Nephrolithiasis
Keywords
Ureteroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low energy high frequency
Arm Type
Experimental
Arm Description
Ureteroscopy with laser settings of low energy & high frequency with aim of stone dusting
Arm Title
High energy low frequency
Arm Type
Active Comparator
Arm Description
Ureteroscopy with laser settings of low energy high frequency with aim of stone fragmentation and basket extraction of fragments
Intervention Type
Device
Intervention Name(s)
Ureteroscopy
Intervention Description
Ureteroscopy with laser stone fragmentation
Primary Outcome Measure Information:
Title
Stone free rate
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Duration of operation
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Freifeld
Phone
+97248250843
Email
yuvalfr@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Freifeld
Organizational Affiliation
Carmel MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuval Freifeld
Phone
+97248250843
Email
yuvalfr@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Yuval Freifeld, MD

12. IPD Sharing Statement

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

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