Feasibility Study Of Ambulatory Monitoring System

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04959136

Enrollment

300

Registered

2021-07-13

Start date

2021-09-01

Completion date

2024-12-30

Last updated

2021-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Monitoring

Brief summary

This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.

Detailed description

This is a pre-market, open label, prospective, non-randomized, data collection clinical research study conducted at one investigational site. This study will collect open comments, user feedback and parameter raw data to support product development. Raw parameter data will be collected from electrocardiogram (ECG), Pulse Rate (PR), respiratory rate (RR), peripheral capillary oxygen saturation (SpO2), non-invasive blood pressure (NIBP), and temperature. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor. Participation is expected to last no more than 72 hours.

Interventions

DEVICEAmbulatory Monitoring Solution

Aim is to evaluate PR; RR; NIBP, cNIBP, SpO2 and arterial blood pressure with investigational Ambulatory Monitoring Solution (AMS)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Days to 100 Years

Healthy volunteers

Inclusion criteria

1. Are able to provide written informed consent or have a legally designated representative provide written informed consent; 2. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND 3. Are an adult 18 years or older, or pediatric or neonate subject.

Exclusion criteria

1. Are known to be pregnant; 2. Are breastfeeding; OR 3. Are suffering from infections that require isolation.

Design outcomes

Primary

Measure	Time frame	Description
User feedback	through study completion, average of one day per subject	This is an early feasibility study intended to elicit user feedback in a hospital setting in order to improve device functionality and further development of the measurement algorithms. User feedback will be collected by open comments field in CRF.
Collection of electronic parameter data	2 hours up to 3 days	Electronic device files from patient sensors will be collected for each subject.

Secondary

Measure	Time frame	Description
Safety information	through study completion and issues resolved, average of one day per subject	To collect safety information, including type and number of AEs, SAEs, and device issues.

Contacts

Primary ContactSatu Nikander

satu.nikander@ge.com+ 358 40 847 0008

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026