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Assessment of CSF Shunt Flow With Thermal Measurements B (STEALTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05432986
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : March 30, 2023
Sponsor:
Information provided by (Responsible Party):
Rhaeos, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Hydrocephalus Device: Thermal Anisotropy Measurement 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Groups and Cohorts
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Group/Cohort Intervention/treatment
Hydrocephalus Patients
Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.
 Device: Thermal Anisotropy Measurement Device
A wireless device for non-invasively assessing CSF shunt flow.
Other Name: FlowSense


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic Performance [ Time Frame: 7-day follow-up period ]
    sensitivity and specificity of study device output


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hydrocephalus patients with an existing ventriculoperitoneal shunt and shunt malfunction symptoms
Criteria

Inclusion criteria

  1. Existing ventriculoperitoneal CSF shunt on which the patient is dependent
  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 seven 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 obstruction
  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 main study enrollments of the same patient are disallowed)
  8. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432986


Contacts
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Contact: Anna Somera 855-814-3569 info@rhaeos.com

Locations
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United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Klaudia Dziugan       kdziugan@luriechildrens.org   
Northwestern Memorial Hospital Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Ashkan Zarrieneh       ashkan.zarrieneh@northwestern.edu   
University of Illinois Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Linda Rose-Finnell       lfinnell@uic.edu   
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Diego Morales       d.morales@wustl.edu   
United States, New York
Lenox Hill Hospital Not yet recruiting
New York, New York, United States, 10075
Contact: Faith Singh       fsingh3@northwell.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Hazani Benitez-Rosas       hazani.benitez-rosas@duke.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Sarah Mierke       sarah.mierke@cchmc.org   
Contact: Linda Lovell-Ewen       linda.lovell-ewen@cchmc.org   
Sponsors and Collaborators
Rhaeos, Inc.
Investigators
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Principal Investigator: Sandi Lam, MD, MBA Lurie Children's Hospital
More Information
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Responsible Party: Rhaeos, Inc.
ClinicalTrials.gov Identifier: NCT05432986    
Other Study ID Numbers: 2021-01
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023

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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
Additional relevant MeSH terms:
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Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases