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NCT00739284 Clinical Trial

A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney

Kidney Disease Clinical Trial

— JJVsPCN08  

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00739284
Other study ID # JJVsPCN08
Secondary ID
Status Recruiting
Phase N/A
First received August 20, 2008
Last updated August 20, 2008
Start date August 2008

Study information
Verified date August 2008
Source Rabin Medical Center
Contact Shay Golan, MD
Phone 972-3-9376560
Email shayg@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics CommissionUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying fever or renal failure, an urgent drainage might be needed. This can be done either by placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the question which of the two is preferred. A debate exist regarding the effectiveness of each procedure to improve symptoms, renal function and treating an infection. Our goal is to resolve this debate and to state whether one way is preferred on the other.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: Patient suffering from obstructed kidney by a stone and at least one of these situations:

1. fever (above 38c)

2. A rise in creatine to above 1.5

3. Pain resistent to multiple analgetic treatments

Exclusion Criteria:

- Patients with medical condition that prevent the use of one of the procedures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• nephrostomy tube and ureteral stent

Locations
Country Name City State
Israel Rabin medical center Petach Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary quality of life
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