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Urinary Sensor for Cystourethrography

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ClinicalTrials.gov Identifier: NCT00547820
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : October 28, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients

Condition or disease Intervention/treatment
Radiation Dose During VCUG Other: placebo Device: Urinary sensor

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Urinary Sensor for Cystourethrography
Study Start Date : July 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: A
with application of urinary sensor
Device: Urinary sensor
Placebo Comparator: B
without use of urinary sensor
Other: placebo


Outcome Measures

Primary Outcome Measures :
  1. Radiation dose during VCUG procedure

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children referred for VCUG procedure at out department

Exclusion Criteria:

  • children with pacemakers
  • decline to participate
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547820


Locations
Israel
Department of Diagnostic Imaging, Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Olga R Brook, MD Department of Diagnostic Imaging, Rambam Health Care Campus
More Information

ClinicalTrials.gov Identifier: NCT00547820     History of Changes
Other Study ID Numbers: OBrook2518CTIL
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: October 28, 2009
Last Verified: October 2007

Keywords provided by Rambam Health Care Campus:
radiation dose
VCUG
pediatric patients