Healthy
Conditions
Keywords
ACL Patch Placement
Brief summary
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.
Interventions
DEVICEACL Patch
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.
Sponsors
Biosense Webster, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites. | 6 hours |
Outcome results
None listed