STEALTH: Assessment of CSF Shunt Flow With Thermal Measurements B

• Sponsor: Rhaeos, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05432986
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 2.8
• Patients Per Site: 50
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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	Phase
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 in need of surgical revision.

Study Design

• Study Type: Observational
• Anticipated 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: Jul 7, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	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 Names: FlowSense

Outcome Measures

Primary Outcome Measures

1. Diagnostic Performance [14-day follow-up period]

   accuracy of study device output as a predictor of surgical shunt revision

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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 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

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois Chicago	Chicago	Illinois	United States	60612
2	Washington University in St. Louis	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Rhaeos, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rhaeos, Inc.
• ClinicalTrials.gov Identifier: NCT05432986
• Other Study ID Numbers: 2021-01
• First Posted: Jun 27, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hydrocephalus

Study Results

No Results Posted as of Jul 11, 2022