INVSENSOR00011 Clinical Performance Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-23

Study Completion Date

2018-07-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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INVSENSOR00011 Test group

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

Group Type EXPERIMENTAL

INVSENSOR00011

Intervention Type DEVICE

INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.

Interventions

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INVSENSOR00011

INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes