Verify the Performance of the Neutral Electrode (NE) Adhesives

NCT05376787 | Completed Results FDA Device

• 1 other identifier: F2P27778
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 placed on the body of patients undergoing surgery that involves the use of electric current, to protect them from the harmful effects of the electricity.

Conditions

Adhesion of the Neutral Electrode 21pad

Outcome Measures

Primary Outcomes (1)

• Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation

  To determine the percentage of adhesion separation by only measuring test results that had no more than 5% of the NE adhesive area separated. At Point A where the NE connects to the pad, connect a cord to pull on the cable. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad and in a direction away from the center of the pad, with 10 to 11N (1.02 to 1.12kg) of force in the direction along the minor dimension of the pad. Set the height of the pulley so that the direction of pull shall be approximately co-planer with the plane of the connection point of the NE. The pull shall be performed by a cord connected to the NE at the cable connection point. See Figure 2 for the pull set up. The weights provide the required pull force. Start timer. At 10 mins, change direction of pull to y direction by rotating the pulley system 90 degrees as shown in Figure 2 - apply 10 to 11 N force at Point A in direction of y ray which is in a plane parallel to the pad. Start timer. At 10 mins

  Up to 20 minutes - (10 minutes w. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad & At 10 mins, change direction of pull to y direction)

Study Arms (1)

Healthy Subjects

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.

Device: Medline NE Grounding Pad

Interventions

Medline NE Grounding Pad DEVICE

Split Universal Grounding Pads

Healthy Subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will consist of at least 10 males and 10 females. Participants must be healthy and of at least 18 years of age. Participants must also fit inclusion and exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medline Industries: lead
• F2 Labs: collaborator

Study Sites (1)

F2 Labs

Damascus, Maryland, 20872, United States

Location

Results Point of Contact

• Title: Wendy Fuster
• Organization: F2 Labs

wfuster@f2labs.com

3013682586

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: May 30, 2022
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)