INVSENSOR00027 Fall Detection Clinical Performance Study | NCT04224753

NCT04224753

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INVSENSOR00027 Test group	Experimental	The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.	Device: INVSENSOR00027

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INVSENSOR00027	Device	Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.	INVSENSOR00027 Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1-5 hours

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ahmed Alghazi	Masimo Corporation	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Masimo Clinical Lab		Irvine	California	92618	United States

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

1 subject excluded as study procedures were not followed per protocol.

Posted

Number

percentage of falls detected

1-5 hours

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.