An interventional study of wireless thermal anisotropy measurement device in Hydrocephalus, sponsored by Rhaeos, Inc.. Recruiting at 1 site in United States. Open to participants aged 6 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Rhaeos, Inc. · Not applicable, Interventional, and Basic science
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 headache and non-headache periods.
190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.
This study's planned enrollment of 29 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.
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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.
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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.
hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months
Device: wireless thermal anisotropy measurement device
Wireless wearable thermal anisotropy measurement device designed for use at home
Correlation Between Study Device Flow Measurement and Subject-reported Headaches
Exploratory analysis to determine the relationship between headaches (subject-reported headache and non-headache periods) and measured flow. Data will be analyzed using the Point-Biserial Correlation Coefficient between headaches periods (headache and non-headache periods) and thermal flow score (flow score derived from algorithm analysis of raw thermal data)
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2025, 7 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 7 months is below that.
How these figures are worked out, and which studies are left out of them.
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Rhaeos, Inc.