Form, Fit, and Function of INVSENSOR00061

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

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2024-03-28

Brief Summary

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The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.

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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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Test Subjects

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVENSOR00061

Group Type EXPERIMENTAL

INVSENSOR00061

Intervention Type DEVICE

Noninvasive pulse oximetry and pulse rate device

Interventions

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INVSENSOR00061

Noninvasive pulse oximetry and pulse rate device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is a full-term newborn (37 weeks) - up to 18 months of age.
* The parent(s) or guardian(s) of minor subjects are able to read and communicate in English and understand the study and the risks involved.

Exclusion Criteria

* Subject has underdeveloped skin.
* Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
* Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Minimum Eligible Age

0 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes