Assessment of CSF Shunt Flow With Thermal Measurements B

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Brief Title

Assessment of CSF Shunt Flow With Thermal Measurements B

Official Title

Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B

Brief Summary

      This study evaluates the performance of a non-invasive thermal measurement device for
      assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt
      malfunction will be evaluated with the study device.

Detailed Description

      Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing
      shunt malfunction symptoms will be recruited by the clinical investigators at each
      investigational site in accordance with the inclusion and exclusion criteria. Assessment of
      shunt flow will be performed non-invasively with the study device; physician and clinical
      staff will be blinded to the device result. Standard-of-care assessment of shunt function
      will be performed and surgical intervention will occur based on the judgement of the treating
      neurosurgeon without the use of study device data. This trial will evaluate the ability of
      the study device to identify shunt malfunctions in need of surgical revision.

Study Type


Primary Outcome

Diagnostic Performance




Thermal Anisotropy Measurement Device

Study Arms / Comparison Groups

 Hydrocephalus Patients
Description:  Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

July 7, 2022

Completion Date

October 2022

Primary Completion Date

October 2022

Eligibility Criteria

        Inclusion criteria

          1. Existing ventriculoperitoneal CSF shunt

          2. At least one symptom of shunt malfunction as determined by the investigator, such as
             but not limited to seizure, fever, headache, vision problems, dizziness,
             disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or
             staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait
             disturbance, and loss of sensory or motor function

          3. Suspicion of shunt obstruction warrants the performance of a test for this condition
             in the investigator's judgement

          4. 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

          5. Available for follow-up for up to fourteen days

          6. Signed informed consent by patient or a parent, legal guardian, health care agent, or
             surrogate decision maker (according to local statutes, and collectively referred to as
             "surrogates" in this protocol)

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

        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 with suspected

          2. Use of the study device would interfere with standard patient care, or emergency
             surgery that cannot be delayed

          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. Participation in the study will interfere with, or be detrimental to, administration
             of optimal health-care to the subject

          7. Prior enrollment in this study (multiple enrollments of the same patient are

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




N/A - N/A

Accepts Healthy Volunteers



Sandi Lam, MD, MBA, 855-814-3569, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Rhaeos, Inc.

Study Sponsor

Sandi Lam, MD, MBA, Principal Investigator, Lurie Children's Hospital

Verification Date

August 2022