Eligibility, any sex, with Adhesion of the Neutral Electrode 21pad. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive SeparationPrimary· 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)
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 per
Group
Value
95% CI
Healthy Subjects
39
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Medline Industries
Last refreshed: 17 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05376787.