Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

Hydrocephalus Clinical Trial

Official title:

Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086561
• Other study ID #: 2023-01
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Rhaeos, Inc.
• Contact: Anna Somera
• Phone: 855-814-3569
• Email: info[@]rhaeos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Existing ventriculoperitoneal CSF shunt

2. Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device

3. Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home)

4. Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)

5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)

6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English

7. Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision

8. Patient is at least 6 years old but not more than 80 years old

Exclusion Criteria:

1. Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt

2. Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evolution.

3. Presence of an interfering open wound or edema over any portion of the shunt

4. Patient-reported history of adverse skin reactions to adhesives

5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable

6. Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home)

7. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance

8. 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 healthcare to the subject

9. Prior enrollment in this study

10. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• Thermal Anisotropy Measurement Device
The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rhaeos, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Temperature	Exploratory assessment of thermal skin measurements taken with the study device	up to 90 days
Primary	Acceleration	Exploratory assessment of accelerometer measurements taken with the study device	up to 90 days