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AMS Evaluation Study

NCT ID: NCT04472208

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2021-10-14

Brief Summary

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A study to evaluate the operational and functional features of the Ambulatory Monitor Solution (AMS) as well as the ease of use of the system.

Detailed Description

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The study is going to be conducted to collect feedback from the users about operation of AMS collect parameter raw data from patients in hospital ward setting using the investigational system for use in current and future AMS engineering and regulatory purposes as deemed appropriate by the Sponsor.

Conditions

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Patient Monitoring

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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Ambulatory Monitoring Solution

The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices.

Group Type EXPERIMENTAL

Ambulatory monitoring solution

Intervention Type DEVICE

Subjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor.

Interventions

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Ambulatory monitoring solution

Subjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female aged 18 years or older (≥18 years);
2. Able and willing to provide written informed consent independently.

Exclusion Criteria

1. Have previously participated in this study (no subject may participate more than once);
2. Have an implantable pacemaker;
3. Diagnosed with infection requiring isolation; OR
4. Known to be pregnant and/or breast feeding;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meera Joshi, MBBS

Role: PRINCIPAL_INVESTIGATOR

St. Marys Hospital, London

Locations

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Chelsea and Westminster Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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123.04-2017-GES-0005

Identifier Type: -

Identifier Source: org_study_id