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

Primary Purpose

Hydrocephalus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermal Anisotropy Measurement Device
Sponsored by
Rhaeos, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hydrocephalus

Eligibility Criteria

6 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Existing ventriculoperitoneal CSF shunt 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 Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home) 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) Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision Patient is at least 6 years old but not more than 80 years old Exclusion Criteria: Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt 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. Presence of an interfering open wound or edema over any portion of the shunt Patient-reported history of adverse skin reactions to adhesives Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home) Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance 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 Prior enrollment in this study Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Feasibility Assessment Cohort

    Arm Description

    Non-invasive device data acquisition; study is not interventional

    Outcomes

    Primary Outcome Measures

    Skin Temperature
    Exploratory assessment of thermal skin measurements taken with the study device
    Acceleration
    Exploratory assessment of accelerometer measurements taken with the study device

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Rhaeos, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06086561
    Brief Title
    Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
    Official Title
    Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rhaeos, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hydrocephalus

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Feasibility Assessment Cohort
    Arm Type
    Experimental
    Arm Description
    Non-invasive device data acquisition; study is not interventional
    Intervention Type
    Device
    Intervention Name(s)
    Thermal Anisotropy Measurement Device
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Skin Temperature
    Description
    Exploratory assessment of thermal skin measurements taken with the study device
    Time Frame
    up to 90 days
    Title
    Acceleration
    Description
    Exploratory assessment of accelerometer measurements taken with the study device
    Time Frame
    up to 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Existing ventriculoperitoneal CSF shunt 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 Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home) 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) Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision Patient is at least 6 years old but not more than 80 years old Exclusion Criteria: Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt 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. Presence of an interfering open wound or edema over any portion of the shunt Patient-reported history of adverse skin reactions to adhesives Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home) Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance 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 Prior enrollment in this study Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna Somera
    Phone
    855-814-3569
    Email
    info@rhaeos.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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