NCT01590368

Brief Summary

It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Status
unknown

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

May 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

Same day

First QC Date

May 1, 2012

Last Update Submit

May 2, 2012

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

  • Product Performance : Remain in place

    Ability to remain in place for a duration of 30 minutes (as per intended use)

    30 minutes

  • Product Performance: Perform

    Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use.

    30 minutes

Secondary Outcomes (2)

  • Safety: Adverse Events

    2 days

  • Skin Rating

    2 days

Study Arms (2)

Marketed electrode

OTHER

The currently marketed electrodes using the current CE marked adhesive

Device: Marketed electrode

Modified hydrogel

ACTIVE COMPARATOR

Electrodes with the new modified adhesive - the "test" electrodes

Device: Modified "test" electrode

Interventions

Marketed electrodeDEVICE

12 electrodes will be placed on the subject for an ECG reading to be taken

Marketed electrode
Modified "test" electrodeDEVICE

12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken

Modified hydrogel

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written informed consent
  • Be a healthy volunteer and be over 18 years of age
  • Willing to attend two scheduled visits for application and removal of the device and adverse event review
  • Have healthy unbroken skin

You may not qualify if:

  • Subjects with a history of sensitivity to any one of the components of the device being studied
  • Subjects who have a history of skin related disorders to the chest.
  • Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes
  • Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Barbara A Schofield

    North Cheshire Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 2, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 4, 2012

Record last verified: 2012-05