Trial Outcomes & Findings for INVSENSOR00027 Fall Detection Clinical Performance Study (NCT NCT04224753)
NCT ID: NCT04224753
Last Updated: 2020-06-11
Results Overview
For each subject's fall simulation, INVSENSOR00027 output will be computed. In order to calculate sensitivity of the device, true positives and false negatives need to be accounted for. For each event of fall, the sensor's output is observed. Fall that is correctly identified is marked as true positive (TP), whereas a missed detection is marked as false negative (FN). Combining the two, test sensitivity is computed by multiplying TP by 100 and dividing that over the sum of TP and FN.
COMPLETED
NA
51 participants
1-5 hours
2020-06-11
Participant Flow
Participant milestones
| Measure |
INVSENSOR00027 Test Group
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INVSENSOR00027 Fall Detection Clinical Performance Study
Baseline characteristics by cohort
| Measure |
INVSENSOR00027 Test Group
n=51 Participants
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-5 hoursPopulation: 1 subject excluded as study procedures were not followed per protocol.
For each subject's fall simulation, INVSENSOR00027 output will be computed. In order to calculate sensitivity of the device, true positives and false negatives need to be accounted for. For each event of fall, the sensor's output is observed. Fall that is correctly identified is marked as true positive (TP), whereas a missed detection is marked as false negative (FN). Combining the two, test sensitivity is computed by multiplying TP by 100 and dividing that over the sum of TP and FN.
Outcome measures
| Measure |
INVSENSOR00027 Test Group
n=50 Participants
The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.
|
|---|---|
|
Sensitivity of INVSENSOR00027's Fall Detection.
|
93.9 percentage of falls detected
|
Adverse Events
INVSENSOR00027 Test Group
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