Healthy
Conditions
Brief summary
This study assesses INVSENSOR00027's clinical performance for fall detection.
Interventions
DEVICEINVSENSOR00027
Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 45 years old * Physical status of ASA I or II * Subjects must be able to read and communicate in English * Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement * Has completed Health Assessment Questionnaire and passed health assessment screening
Exclusion criteria
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study * Inability to tolerate physical activities including jumping and fall simulation * Nursing female volunteers * Excluded at the Principal Investigator's discretion * Refusal to take the pregnancy test (for female subjects) * Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population. * Refusal to shave hair (chest) off areas where sensors will be applied (male subjects)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of INVSENSOR00027's Fall Detection. | 1-5 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | INVSENSOR00027 Test Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Race/Ethnicity, Customized African American | 8 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 10 Participants |
| Race/Ethnicity, Customized Caucasian | 18 Participants |
| Race/Ethnicity, Customized Hispanic | 13 Participants |
| Race/Ethnicity, Customized Middle Eastern | 2 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Sensitivity of INVSENSOR00027's Fall Detection.
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.
Time frame: 1-5 hours
Population: 1 subject excluded as study procedures were not followed per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00027 Test Group | Sensitivity of INVSENSOR00027's Fall Detection. | 93.9 percentage of falls detected |