Thermal Measurement Device for Hydrocephalus

Overseen By Anna Somera

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rhaeos, Inc.

Disqualifiers: Multiple shunt catheters, Deep shunt, Open wound, Silicone allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

29 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with hydrocephalus who experience headaches. Participants will use a wireless device to measure CSF shunt flow during headache and non-headache periods. Specific eligibility criteria are not provided, but typically include being diagnosed with the condition and consenting to participate.

Inclusion Criteria

Existing ventriculoperitoneal CSF shunt

I can attend both remote and in-person follow-ups for 30 days.

I have had headaches on most days for the last 3 months.

Exclusion Criteria

Investigator judges that the subject is unlikely to successfully take reliable measurements at home

Prior enrollment in this study

Presence of more than one distal shunt catheter in the study device measurement region

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

Participants use the device to measure cerebrospinal fluid (CSF) shunt flow during headache and non-headache periods

4 weeks

Multiple self-administered measurements

Follow-up

Participants are monitored for safety and effectiveness after the measurement period

4 weeks

Treatment Details

Interventions

• Wireless Thermal Anisotropy Measurement Device

Trial Overview The study is testing a wireless thermal anisotropy measurement device's ability to assess cerebrospinal fluid (CSF) shunt flow in patients with hydrocephalus. The device will be used by participants themselves at different times to monitor changes.

Participant Groups

Group I: CSF Shunted Patients with Chronic Headaches Experimental Treatment 1 Intervention

hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months

Who Is Running the Clinical Trial?

Rhaeos, Inc.

Lead Sponsor

Trials

11

Recruited

690+