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New treatment option for Hydrocephalus
Official title Flow Detection in Open and Closed Shunt Valve Periods
ClinicalTrials.gov ID: NCT07478926
What this study is testing
- What it's testing
- This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Inclusion and
You likely can't join if
- for Roll-In people Inclusion criteria
- Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively
- Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is...
- Signed informed consent by subject or a parent or legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Subject-reported or documented history of successful valve adjustment(s) Inclusion and Exclusion Criteria for Main Study people Inclusion criteria
- Existing ventricular CSF shunt
See the full eligibility criteria
Who can join
- Inclusion and
What rules you out
- for Roll-In people Inclusion criteria
- Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively
- Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
- Signed informed consent by subject or a parent or legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Subject-reported or documented history of successful valve adjustment(s) Inclusion and Exclusion Criteria for Main Study people Inclusion criteria
- Existing ventricular CSF shunt
- Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) people with planned "virtual off" measurement: -Existing ventricular CSF shunt...
- Presence of more than one distal shunt catheter in the study device measurement region
- Presence of an interfering open wound or edema in the study device measurement region
- Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement
- Shunt valve is set to an opening pressure of \>= 300 mm H2O, or the shunt system is otherwise set to substantially prevent shunt flow (e.g. Certas Plus valve programmed to a setting of 8 or a ligated shunt)
- Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)
- Subject has more than one intact and presumed functional distal catheter
- Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives
- Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days
- Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal...
- Prior enrollment in this study
- Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study Exclusion Criteria for Main Study people Exclusion criteria
- Presence of more than one distal shunt catheter in the study device measurement region
- Presence of an interfering open wound or edema in the study device measurement region
- Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement
- Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives
- Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days
- Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal...
- Prior enrollment in this study
- Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
- Previous participation in a Rhaeos clinical study in which the study device (current generation) was used to acquire measurement data people with planned "valve normal" measurements:
- Shunt system is set to substantially prevent shunt flow (e.g. ligated shunt)
- Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)
- Subject has more than one intact and presumed functional distal catheter
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.