Portrait Mobile Monitoring Solution V2.0 External Evaluation

General Electric (GE)

Status: Begins enrollment this month

Conditions: Monitoring

Treatments: Device: Continuous Monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT07309809

SA-000173

Details and patient eligibility

About

The purpose of this study is to collect and assess feedback from the users regarding the functionality and performance of the Portrait Mobile Monitoring Solution V2.0. In addition, this study aims to collect raw parameter data from the investigational devices for use in current and future Portrait Mobile development, including engineering purposes as deemed appropriate by the Sponsor.

Full description

Subjects will be enrolled from a general hospital ward to receive continuous monitoring for up to 72 hours by the Portrait Mobile Monitoring Solution V2.0. After the completion of that monitoring, both the clinician and the subject will complete a feedback survey about their experience with the device. The surveys along with raw data from the device will be collected from each subject.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant is age 18 years or older (≥18 years).
2. Participant must have the ability to understand and provide written informed consent.
3. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure.
4. Participant must be willing and able to comply with study procedures and duration.

Exclusion criteria

1. Known to be pregnant and/or breast feeding.
2. Diagnosed with infection requiring isolation.
3. Are immunocompromised.
4. Have previously participated in this study (no subject may participate more than once).
5. Subjects with Implantable Minute Ventilation Rate Responsive Pacemakers should be excluded from respiration rate monitoring.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Continuous Monitoring with Portrait Mobile

Experimental group

Description:

Subjects will be monitored with the Portrait Mobile Monitoring Solution for up to 72 hours

Treatment:

Device: Continuous Monitoring