An observational study in Adhesion of the Neutral Electrode 21pad, sponsored by Medline Industries. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Medline Industries · Observational
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.
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 force pulling the neutral electrode away from your body. The force will be applied for 10 minutes on each neutral electrode in one direction, and then for another 10 minutes in a second direction. Site staff will mark any areas of separation and the neutral electrodes will be removed.
Medline Industries is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Split Universal Grounding Pads
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
Time frame: 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)
| Milestone | Healthy Subjects |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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
| Tests | Healthy Subjects |
|---|---|
| Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation | 39 |
Collected over Up to 20 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Subjects | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Healthy Subjects |
|---|---|
| <=18 years | 20 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Healthy Subjects |
|---|---|
| Female | 10 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | Healthy Subjects |
|---|
| Region of Enrollment(participants) | Healthy Subjects |
|---|---|
| United States | 20 |
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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