Feasibility and Performance Evaluation for INVSENSOR00024

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2019-11-08

Brief Summary

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This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.

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Detailed Description

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Conditions

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Evaluation of SpO2 Performance

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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RD SET Neo SpO2

All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.

Group Type EXPERIMENTAL

RD SET Neo SpO2

Intervention Type DEVICE

All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.

Interventions

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RD SET Neo SpO2

All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Less than or equal to 1 month of age
* Weight \<3kg
* Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion Criteria

* Subjects with underdeveloped skin
* Subjects with abnormalities at the planned application sites that would interfere with system measurements
* Subjects with known allergic reactions to foam/rubber products and adhesive tape
* Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes