INVSENSOR00027 Fall Detection Clinical Performance Study

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: INVSENSOR00027

Study type: Interventional

Funder types: Industry

Identifiers

NCT04224753

TP-19817A

Details and patient eligibility

About

This study assesses INVSENSOR00027's clinical performance for fall detection.

Enrollment: 51 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

INVSENSOR00027 Test group

Experimental group

Description:

The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.

Treatment:

Device: INVSENSOR00027