Radiation Dose During VCUGNCT00547820
Urinary Sensor for Cystourethrography
A study testing Urinary sensor in people with Radiation Dose During VCUG, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Radiation Dose During VCUG
- What is being tested?
- Urinary sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children referred for VCUG procedure at out department
Who cannot join
- children with pacemakers
- decline to participate
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Diagnostic Imaging, Rambam Health Care Campus
Haifa, 31096
About this study
Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients
Read the 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.
- Conditions
- Radiation Dose During VCUG
- Being tested
- placebo, Urinary sensor
- Keywords
- radiation dose, VCUG, pediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Urinary sensorDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | with application of urinary sensor Receives: Device: Urinary sensor |
| B | Placebo comparator | without use of urinary sensor Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose during VCUG procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Dose During VCUGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Olga R Brook, MD, Principal investigator, Department of Diagnostic Imaging, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547820
- Sponsor's protocol ID
- OBrook2518CTIL
- Status last verified
- Oct 2007
- First submitted
- 20 Oct 2007
- Last updated
- 28 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Sensor for Cystourethrography
- ClinicalTrials.gov ID
- NCT00547820
- Acronym / sponsor ID
- OBrook2518CTIL
- Conditions
- Radiation Dose During VCUG
- Keywords
- radiation dose, VCUG, pediatric patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Urinary sensorwith application of urinary sensor |
| B | Placebo comparator | Other: placebowithout use of urinary sensor |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children referred for VCUG procedure at out department
Key exclusion criteria (2 listed)
- children with pacemakers
- decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo | Other | B |
| Urinary sensor | Device | A |
Primary outcome
Radiation dose during VCUG procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga R Brook, MD principal investigator
Department of Diagnostic Imaging, Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary sensor in people with Radiation Dose During VCUG, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose during VCUG procedure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2009.