Trial Outcomes & Findings for Assessment of CSF Shunt Flow With Thermal Measurements B (NCT NCT05432986)

NCT ID: NCT05432986

Last Updated: 2025-02-20

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 141 participants
• Primary outcome timeframe: 7-day follow-up period
• Results posted on: 2025-02-20

Participant Flow

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	141
Overall Study COMPLETED	132
Overall Study NOT COMPLETED	9

Reasons for withdrawal

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 Withdrawal by Subject	2
Overall Study incomplete measurement	7

Baseline Characteristics

11 values missing

Baseline characteristics by cohort

Measure	Hydrocephalus Patients n=139 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	11 years n=139 Participants
Sex: Female, Male Female	52 Participants n=128 Participants • 11 values missing
Sex: Female, Male Male	76 Participants n=128 Participants • 11 values missing
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=139 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	107 Participants n=139 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=139 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=139 Participants
Race (NIH/OMB) Asian	3 Participants n=139 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=139 Participants
Race (NIH/OMB) Black or African American	17 Participants n=139 Participants
Race (NIH/OMB) White	95 Participants n=139 Participants
Race (NIH/OMB) More than one race	2 Participants n=139 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=139 Participants

PRIMARY outcome

Timeframe: 7-day follow-up period

Population: Study participants with complete study device measurements using the random forest algorithm, excluding incorrectly placed devices.

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

Outcome measures

Measure	Hydrocephalus Patients n=70 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	88.9 percent of ground truth positive cases Interval 68.4 to 100.0

PRIMARY outcome

Timeframe: 7-day follow-up period

Population: Subjects with complete study device measurements using the random forest algorithm, excluding incorrectly placed devices.

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

Outcome measures

Measure	Hydrocephalus Patients n=70 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	49.2 percent of ground truth negative cases Interval 36.6 to 61.7

Adverse Events

Hydrocephalus Patients

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hydrocephalus Patients n=139 participants at risk 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.
Skin and subcutaneous tissue disorders skin redness	2.9% 4/139 • Number of events 4 • 20 minutes Patients were evaluated for adverse events during the use of the study device and for a period of 20 minutes thereafter. The total at risk count (N=139) includes all subjects in which a device measurement was attempted (132 subjects with complete measurements and 7 subjects with incomplete measurements)

Additional Information

Anna Somera

Rhaeos, Inc.

Phone: 855-814-3569

Email: info@rhaeos.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place