CARTO 3 Human Patch Study

Biosense Webster

Status: Withdrawn

Conditions: Healthy

Treatments: Device: ACL Patch

Study type: Observational

Funder types: Industry

Identifiers

NCT00767390

Rep2952

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 1 patient group

ACL Patch

Treatment:

Device: ACL Patch