Hydrocephalus
Conditions
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.
Interventions
A wireless device for non-invasively assessing CSF shunt flow.
Sponsors
Rhaeos, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Existing ventriculoperitoneal CSF shunt * At least one symptom of shunt malfunction as determined by the investigator, including 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 * Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement * 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 follow-up for up to fourteen days * Signed informed consent by patient or a parent, legal guardian, health care agent, or legally authorized representative. * Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision
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 with suspected obstruction * Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed * 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 * Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject * Prior enrollment in this study (multiple enrollments of the same patient are disallowed) * Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Device Sensitivity | 14-day follow-up period | Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative. |
| Study Device Specificity | 14-day follow-up period | Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydrocephalus Patients Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.
Thermal Anisotropy Measurement Device: A wireless device for non-invasively assessing CSF shunt flow. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Hydrocephalus Patients |
|---|---|
| Age, Continuous | 22 years STANDARD_DEVIATION 19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 3 Participants |
| Race/Ethnicity, Customized Race More than one Race | 1 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 8 Participants |
| Race/Ethnicity, Customized Race White | 26 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Study Device Sensitivity
Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.
Time frame: 14-day follow-up period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrocephalus Patients | Study Device Sensitivity | 88 percent |
Primary
Study Device Specificity
Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.
Time frame: 14-day follow-up period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrocephalus Patients | Study Device Specificity | 87 percent |