An observational study in Hydrocephalus, sponsored by Rhaeos, Inc.. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Rhaeos, Inc. · Observational
This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.
190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.
This study's planned enrollment of 17 is below the median of 73 across 86 observational studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →Rhaeos, Inc. is the lead sponsor of 16 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric and adult shunt-dependent hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation without use of the study device data will be enrolled in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with an existing implanted ventriculoperitoneal shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation
Device: Thermal Anisotropy Measurement Device
A wireless device for non-invasively assessing CSF shunt flow
Also known as: FlowSense
Flowsense Sensitivity
The study device will yield an output of either "flow confirmed" or "flow not confirmed." Based on this assessment and the standard-of-care clinical treatment, each subject will fall into one of the following categories: True Positive (TP): Device outputs "flow not confirmed" AND a shunt revision surgery with confirmed shunt failure is performed False Positive (FP): Device outputs "flow not confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed True Negative (TN): Device outputs "flow confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed False Negative (FN): Device outputs "flow confirmed" AND a shunt revision surgery with confirmed shunt failure is performed Study device sensitivity will be calculated as TP / (TP + FN).
Time frame: Upto 7 days
Study device specificity, diagnostic accuracy, positive predictive value (PPV), negative predictive value (NPV), and diagnostic performance
These secondary endpoints do not have associated success criteria. The study is not powered to achieve statistical significance for these endpoints.
Time frame: Up to 7 days
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Rhaeos, Inc.