CARTO 3 Human Patch Study

Biosense Webster, Inc.

Overview

The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. During the study the adhesiveness properties of the patches will be evaluated.

Study Type

OBSERVATIONAL

Conditions

Healthy

Interventions

ACL PatchDEVICE

Observe and characterize the changes in relative conductivity between the six ACL patches over period of six hours. Investigation only involves passive data collection on pressure impact and adhesiveness properties of ACL patches.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Signed Subject Informed Consent Form * Healthy subject * Age Range: 20 - 50 years * BMI - half o the subjects 18-25 and half \>25 * Chest cage normal anatomy and dimensions * No history of skin contact patch allergy, of any kind Exclusion Criteria: * Chest cage bony deformity * Known skin allergies to patches, or dermatological conditions requiring therapy * Presence of any active skin lesion on chest or back * Any condition that preclude subject from lying down for six hours with minimal movement * Pregnancy * Subjects with devices, such as pace makers, IC, loop recorder

Outcomes

Primary Outcomes

Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites.

Time frame: 6 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.