HydrocephalusNCT00652249
Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
An observational study of Hydrocephalus, run by Transonic Systems Inc. at 1 site in United States.
Trial summary
The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve. The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Hydrocephalus
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2010
- Phase
- Observational
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric hydrocephalus patients under the care of the Children's Hospital of Wisconsin, who have had an external ventriculostomy and are instrumented with an Extra-Ventricular Drainage system.
Who may be able to join
- Diagnosed with Hydrocephalus
- Newborn through age 20
- External Ventriculostomy with an Extra-Ventricular Drainage system installed
Who cannot join
- Not diagnosed with Hydrocephalus
- Older than age 20
- No External Ventriculostomy with an Extra-Ventricular Drainage system installed
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve
The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve.
The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag.
By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.
- Conditions
- Hydrocephalus
- Keywords
- Hydrocephalus, shunt dysfunction, shunt flow
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extraventricular Drainage/Pressure | Includes pediatric hydrocephalus patients that are in recovery from shunt explanation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position.
Measured: 24 to 48 hours
Secondary outcomes (1)
Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
Measured: 24 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transonic Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Cornelis J Drost, BS, MS, Principal investigator, Transonic Systems Inc.Bruce A Kaufman, MD, Study director, Children's Hospital and Health System Foundation, Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652249
- Sponsor's protocol ID
- TSI-G-HYDRO-1B-H
- Other IDs
- 2R44NS049680-02
- Status last verified
- Jun 2012
- First submitted
- 31 Mar 2008
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve
- ClinicalTrials.gov ID
- NCT00652249
- Acronym / sponsor ID
- TSI-G-HYDRO-1B-H
- Conditions
- Hydrocephalus
- Keywords
- Hydrocephalus, shunt dysfunction, shunt flow
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Apr 2008 (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.
The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve.
The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag.
By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extraventricular Drainage/Pressure | – | –Includes pediatric hydrocephalus patients that are in recovery from shunt explanation. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric hydrocephalus patients under the care of the Children's Hospital of Wisconsin, who have had an external ventriculostomy and are instrumented with an Extra-Ventricular Drainage system.
Key inclusion criteria (3 listed)
- Diagnosed with Hydrocephalus
- Newborn through age 20
- External Ventriculostomy with an Extra-Ventricular Drainage system installed
Key exclusion criteria (3 listed)
- Not diagnosed with Hydrocephalus
- Older than age 20
- No External Ventriculostomy with an Extra-Ventricular Drainage system installed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position.
Time frame: 24 to 48 hours
1 secondary outcome
Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
Time frame: 24 to 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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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.
Cornelis J Drost, BS, MS principal investigator
Transonic Systems Inc.
Bruce A Kaufman, MD study director
Children's Hospital and Health System Foundation, Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by Transonic Systems Inc. at 1 site in United States.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Jun 2012. 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 United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position. (time frame: 24 to 48 hours). 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 5 Jun 2012.