Trial Outcomes & Findings for Assessment of CSF Shunt Flow With Thermal Measurements A (NCT NCT05015751)

Last Updated: 2024-12-19

Results Overview

Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.

Recruitment status

COMPLETED

Target enrollment

44 participants

Primary outcome timeframe

14-day follow-up period

Results posted on

2024-12-19

Participant milestones
Measure	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.
Overall Study STARTED	44
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	4

Withdrawal data not reported

Assessment of CSF Shunt Flow With Thermal Measurements A

Baseline characteristics by cohort
Measure	Hydrocephalus Patients n=44 Participants 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.
Age, Continuous	22 years STANDARD_DEVIATION 19 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	26 Participants n=5 Participants
Race/Ethnicity, Customized Race · More than one Race	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	8 Participants n=5 Participants

Timeframe: 14-day follow-up period

Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.

Outcome measures
Measure	Hydrocephalus Patients n=23 Participants 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.
Study Device Sensitivity	88 percent

Timeframe: 14-day follow-up period

Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.

Outcome measures
Measure	Hydrocephalus Patients n=23 Participants 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.
Study Device Specificity	87 percent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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