Status:

COMPLETED

Verify the Performance of the Neutral Electrode (NE) Adhesives

Lead Sponsor:

Medline Industries

Collaborating Sponsors:

F2 Labs

Conditions:

Adhesion of the Neutral Electrode 21pad

Eligibility:

All Genders

Brief Summary

The purpose of this research study is to determine the neutral electrode 21pad adhesion to the skin in accordance with international standard IEC 60601-2-2 section 201.15.101.7. A neutral electrode is...

Detailed Description

Two neutral electrodes will be applied to the front of your thighs. The study staff will set up and attach a pulley system to the neutral electrodes. The purpose of the pulley system is to apply a for...

Eligibility Criteria

Inclusion

  • Participants must be willing to comply with all study procedures
  • Participants must be willing to shave, or to have shaved, the sites where the neutral electrodes will be placed.

Exclusion

  • The participant has any skin conditions (e.g. eczema, sensitivities, allergies to adhesives, sunburn, etc.) at the application sites that might be adversely affected by the application of an adhesive pad.
  • The participant is pregnant or breastfeeding.

Key Trial Info

Start Date :

May 30 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 10 2022

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05376787

Start Date

May 30 2022

End Date

June 10 2022

Last Update

October 17 2024

Active Locations (1)

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1

F2 Labs

Damascus, Maryland, United States, 20872