Urinary Sensor for Cystourethrography | NCT00547820

Studies
Urinary Sensor for Cystourethrography

NCT00547820

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Oct 28, 2009Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Radiation Dose During VCUG

Interventions

placebo
Urinary sensor

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Oct 20, 2007

First Submission Date that Met QC Criteria

Oct 22, 2007

First Posted Date

Oct 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2009

Last Update Posted Date

Oct 28, 2009Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	with application of urinary sensor	Device: Urinary sensor
B	Placebo Comparator	without use of urinary sensor	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Other		B
Urinary sensor

Measure	Description	Time Frame
Radiation dose during VCUG procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children referred for VCUG procedure at out department

Exclusion Criteria:

children with pacemakers
decline to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olga R Brook, MD	Department of Diagnostic Imaging, Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Diagnostic Imaging, Rambam Health Care Campus		Haifa		31096	Israel