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NCT02279927 Clinical Trial

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

Nephrolithiasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02279927
Other study ID # CMC-14-0063-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received October 29, 2014
Last updated October 29, 2014
Start date October 2014
Est. completion date December 2015

Study information
Verified date October 2014
Source Carmel Medical Center
Contact Yuval Freifeld
Phone +97248250843
Email yuvalfr@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Ureteroscopy
Ureteroscopy with laser stone fragmentation

Locations
Country Name City State
Israel Carmel Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stone free rate 1 month No
Secondary Duration of operation Immediate No
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