INVSENSOR00011 Clinical Performance Study

Masimo

Status: Terminated

Conditions: Healthy

Treatments: Device: INVSENSOR00011

Study type: Interventional

Funder types: Industry

Identifiers

NCT03641937

TP-19045A

Details and patient eligibility

About

This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 80 years old
• Physical status of ASA I or II
• Must be able to read and communicate in English
• Has signed all necessary related documents, e.g. written informed consent, health assessment questionnaire, gender and ethnicity form, confidentiality agreement
• Passed health assessment screening

Exclusion criteria

• Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
• Inability to tolerate sitting still or minimal movement for at least 30 minutes
• Nursing female volunteers
• Excluded at the Principal Investigator's discretion
• Refusal to take pregnancy test (for female subjects)
• Positive pregnancy tests for female subjects of child bearing potential.
• Refusal to shave hair 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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10 participants in 1 patient group

INVSENSOR00011 Test group

Experimental group

Description:

The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.

Treatment:

Device: INVSENSOR00011