An interventional study of wireless thermal anisotropy measurement device in Hydrocephalus, sponsored by Rhaeos, Inc.. Recruiting at 2 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Rhaeos, Inc. · Not applicable, Interventional, and Device feasibility
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep
190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.
This study's planned enrollment of 28 is below the median of 41 across 97 interventional 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.
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.
Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled.
Device: wireless thermal anisotropy measurement device
Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled.
Device: wireless thermal anisotropy measurement device
Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms
Adverse Device Effects
The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.
Time frame: 30 days
ADEs and SADEs per wear period
rate of ADEs and SADEs per wear period
Time frame: 30 days
ADEs and SADEs per subject
rate of ADEs and SADEs per subject;
Time frame: 30 days
ADEs and SADEs that preclude the continued use of the study device
rate of ADEs and SADEs that preclude the continued use of the study device
Time frame: 30 days
Device deficiencies resulting in incomplete monitoring data
percent of device deficiencies resulting in incomplete monitoring data
Time frame: 30 days
Local skin reactions per wear session;
number of local skin reactions per wear session;
Time frame: 30 days
Usability score
usability score based on post-study survey (1 = easy to use; 5 = difficult to use)
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Aug 2026, 9 months after the start.
Of 40 interventional studies with no phase under Hydrocephalus, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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Rhaeos, Inc.