Urinary Sensor for Cystourethrography

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00547820
First received: October 20, 2007
Last updated: October 27, 2009
Last verified: October 2007
  Purpose

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


Condition Intervention
Radiation Dose During VCUG
Other: placebo
Device: Urinary sensor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Urinary Sensor for Cystourethrography

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Radiation dose during VCUG procedure

Estimated Enrollment: 20
Study Start Date: July 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
with application of urinary sensor
Device: Urinary sensor
Placebo Comparator: B
without use of urinary sensor
Other: placebo

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.

  Eligibility

Ages Eligible for Study:   1 Month to 10 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00547820     History of Changes
Other Study ID Numbers: OBrook2518CTIL
Study First Received: October 20, 2007
Last Updated: October 27, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on September 16, 2014