NCT04472208

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2021

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

July 8, 2020

Last Update Submit

November 2, 2021

Conditions

Patient Monitoring

Outcome Measures

Primary Outcomes (1)

  • User feedback survey about the use of the Ambulatory Monitoring Solution

    The feedback from the clinical users about operational features, alarms, user experience and ease of use of Ambulatory Monitoring Solution will be collected.

    5 days

Other Outcomes (1)

  • Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues

    1 year

Study Arms (1)

Ambulatory Monitoring Solution

EXPERIMENTAL

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

Device: Ambulatory monitoring solution

Interventions

Ambulatory monitoring solutionDEVICE

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.

Ambulatory Monitoring Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Have previously participated in this study (no subject may participate more than once);
  • Have an implantable pacemaker;
  • Diagnosed with infection requiring isolation; OR
  • Known to be pregnant and/or breast feeding;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Study Officials

  • Meera Joshi, MBBS

    St. Marys Hospital, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 15, 2020

Study Start

February 26, 2021

Primary Completion

October 14, 2021

Study Completion

October 14, 2021

Last Updated

November 3, 2021

Record last verified: 2021-11

Locations

GB(1)