Urinary Sensor for Cystourethrography

NCT ID: NCT00547820

Last Updated: 2009-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Radiation Dose During VCUG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

with application of urinary sensor

Group Type EXPERIMENTAL

Urinary sensor

Intervention Type DEVICE

B

without use of urinary sensor

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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placebo

Intervention Type OTHER

Urinary sensor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* children referred for VCUG procedure at out department

Exclusion Criteria

* children with pacemakers
* decline to participate
Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Principal Investigators

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Olga R Brook, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Diagnostic Imaging, Rambam Health Care Campus

Locations

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Department of Diagnostic Imaging, Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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OBrook2518CTIL

Identifier Type: -

Identifier Source: org_study_id

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