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NCT00547820 Clinical Trial

Urinary Sensor for Cystourethrography

Radiation Dose During VCUG Clinical Trial

Official title:
Urinary Sensor for Cystourethrography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00547820
Other study ID # OBrook2518CTIL
Secondary ID
Status Completed
Phase N/A
First received October 20, 2007
Last updated October 27, 2009
Start date July 2007
Est. completion date June 2008

Study information
Verified date October 2007
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients

Description:

It is of immense importance to perform fluoroscopy during voiding phase of VCUG (Voiding Cystourethrogram) procedures in order to rule out vesicourethral reflux. It is difficult to know exactly when a child will start voiding, so the child is intermittently imaged by fluoroscopy. Fluoroscopy involves radiation, and this we try to diminish as much as possible. We suggest application of small urinary sensor in the perineum of the patient, that will signal the beginning of urination, and only then fluoroscopy will begin. This urinary sensor should cut down substantially radiation dose to the patient.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 10 Years
Eligibility Inclusion Criteria:

- children referred for VCUG procedure at out department

Exclusion Criteria:

- children with pacemakers

- decline to participate

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• placebo

Device:
• Urinary sensor

Locations
Country Name City State
Israel Department of Diagnostic Imaging, Rambam Health Care Campus Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiation dose during VCUG procedure