Assessment of CSF Shunt Flow With Thermal Measurements B

Hydrocephalus Clinical Trial

— STEALTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432986
• Other study ID #: 2021-01
• Status: Completed
• Start date: July 7, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2023
• Source: Rhaeos, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 10, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• Thermal Anisotropy Measurement Device
A wireless device for non-invasively assessing CSF shunt flow.

Locations

Country	Name	City	State
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Illinois Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Dayton Children's Hospital	Dayton	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Lenox Hill Hospital	New York	New York
United States	UCSF Benioff Children's Hospital	Oakland	California
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	UCSF Benioff Children's Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Rhaeos, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Performance	sensitivity and specificity of study device output	7-day follow-up period