Trial Outcomes & Findings for Study to Test Sensitivity and Specificity of Passive Wave Pressure Device in Determining Ischemic Stroke (NCT NCT01643525)
NCT ID: NCT01643525
Last Updated: 2024-07-08
Results Overview
Count the number of participants with device related adverse events
Recruitment status
TERMINATED
Target enrollment
29 participants
Primary outcome timeframe
2-3 days, at subject exit (variation of subject exit date depended on when subject obtained their radiology imaging to confirm ischemic stroke)
Results posted on
2024-07-08
Participant Flow
Participant milestones
| Measure |
Nautilus NeuroWave Recording Arm
Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Test Sensitivity and Specificity of Passive Wave Pressure Device in Determining Ischemic Stroke
Baseline characteristics by cohort
| Measure |
Nautilus NeuroWave Recording Arm
n=29 Participants
Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.
|
|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 16.2 • n=93 Participants
|
|
Sex/Gender, Customized
Females Known
|
16 participants
n=93 Participants
|
|
Sex/Gender, Customized
Males Known
|
7 participants
n=93 Participants
|
|
Sex/Gender, Customized
Gender Unknown
|
6 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2-3 days, at subject exit (variation of subject exit date depended on when subject obtained their radiology imaging to confirm ischemic stroke)Count the number of participants with device related adverse events
Outcome measures
| Measure |
Nautilus NeuroWave Recording Arm
n=29 Participants
Nautilus NeuroWaveTM System
Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.
|
|---|---|
|
Number of Participants With Device Related Adverse Events
|
0 Participants
|
Adverse Events
Nautilus NeuroWave Recording Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place