N/A
Completed N=20
Verify the Performance of the Neutral Electrode (NE) Adhesives
Adhesion of the Neutral Electrode 21pad
Source: ClinicalTrials.gov NCT05376787 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation — 39 Tests
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation |
39 | — |
Eligibility Criteria
Inclusion 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05376787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.