Last reviewed · How we verify

NCT05376787

Verify the Performance of the Neutral Electrode (NE) Adhesives

Completed Results posted Last updated 17 October 2024
What this trial tests

trial testing Medline NE Grounding Pad in Adhesion of the Neutral Electrode 21pad in 20 participants. Completed in 10 June 2022.

Timeline
30 May 2022
Primary endpoint
10 June 2022
10 June 2022

Quick facts

Lead sponsorMedline Industries
StatusCompleted
Study typeOBSERVATIONAL
Enrollment20
Start date30 May 2022
Primary completion10 June 2022
Estimated completion10 June 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medline Industries — full company profile →

Who can join

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 Separation Primary · 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

GroupValue95% CI
Healthy Subjects39

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.

Verify or expand the search:

Other Medline Industries trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing