Trial Outcomes & Findings for Verify the Performance of the Neutral Electrode (NE) Adhesives (NCT NCT05376787)
NCT ID: NCT05376787
Last Updated: 2024-10-17
Results Overview
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
COMPLETED
20 participants
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)
2024-10-17
Participant Flow
Participant milestones
| Measure |
Healthy Subjects
Subjects must be 18 years old or over, willing to shave or have shaved the sites where the neutral electrodes will be placed. Subjects also must not be pregnant, breastfeeding, have skin conditions (such as eczema, sensitivities, allergies to adhesives, sunburn).
Medline NE Grounding Pad: Split Universal Grounding Pads
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Subjects
n=20 Participants
Subjects must be 18 years old or over, willing to shave or have shaved the sites where the neutral electrodes will be placed. Subjects also must not be pregnant, breastfeeding, have skin conditions (such as eczema, sensitivities, allergies to adhesives, sunburn).
Medline NE Grounding Pad: Split Universal Grounding Pads
|
|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Healthy participants. Adhesion testing was done on each leg, so there was a total of two tests per participant. A total of 40 tests were done.
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
Outcome measures
| Measure |
Healthy Subjects
n=40 Test legs
Subjects must be 18 years old or over, willing to shave or have shaved the sites where the neutral electrodes will be placed. Subjects also must not be pregnant, breastfeeding, have skin conditions (such as eczema, sensitivities, allergies to adhesives, sunburn).
Medline NE Grounding Pad: Split Universal Grounding Pads
|
|---|---|
|
Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation
|
39 Tests
|
Adverse Events
Healthy Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place