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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02192801
Other study ID # TASMC-13-RC-0022-13-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 30, 2014
Last updated July 16, 2014
Start date April 2014

Study information

Verified date January 2014
Source Tel-Aviv Sourasky Medical Center
Contact Roxana Cleper, MD
Phone 972-3-6972512
Email roxanac@tlvmc.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 30 Years
Eligibility Inclusion Criteria:

- All patients with classic bladder exstrophy treated and followed in Pediatric urology clinic in Dana Children Hospital and Outpatient Clinic

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Israel Pediatric Outpatient Clinic Dana Children Hospital Tel Aviv Sourasky medical center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal function Creatinine and GFR estimation , proteinuria, albuminuria will be assessed as measures of renal function as well as renal mass estimation through renal size as by ultrasound and in certain cases through dimercaptosucicnic acid (DMSA)renal scan 1 day (last visit ) No
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