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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Device Sensitivity | 7-day follow-up period | Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative. |
| Study Device Specificity | 7-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. | 139 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | incomplete measurement | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Hydrocephalus Patients |
|---|---|
| Age, Continuous | 11 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 107 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 95 Participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 139 |
| other Total, other adverse events | 4 / 139 |
| serious Total, serious adverse events | 0 / 139 |
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: 7-day follow-up period
Population: Study participants with complete study device measurements using the random forest algorithm, excluding incorrectly placed devices.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrocephalus Patients | Study Device Sensitivity | 88.9 percent of ground truth positive cases |
Primary
Study Device Specificity
Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.
Time frame: 7-day follow-up period
Population: Subjects with complete study device measurements using the random forest algorithm, excluding incorrectly placed devices.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrocephalus Patients | Study Device Specificity | 49.2 percent of ground truth negative cases |