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

October 29, 2014 updated by: Carmel Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Yuval Freifeld, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stone free rate
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of operation
Time Frame: Immediate
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Yuval Freifeld, Carmel MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 29, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-14-0063-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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