CARTO 3 Human Patch Study - Full Text View

Sponsored by:	Biosense Webster, Inc.
Information provided by:	Biosense Webster, Inc.
ClinicalTrials.gov Identifier:	NCT00767390

Purpose

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.

Condition	Intervention	Phase
Healthy	Device: ACL Patch	Phase I Phase II

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case

Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:

Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	44
Study Start Date:	October 2008

Groups/Cohorts	Assigned Interventions
ACL Patch	Device: ACL 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.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy Volunteers

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767390

Locations

Israel
Rambam Medical Center
Haifa, Israel

Sponsors and Collaborators

Biosense Webster, Inc.

Investigators

Principal Investigator:

Giris Jacob, M.D.

Rambam Health Care Campus

More Information

Responsible Party:	Biosense Webster, Inc. ( Pesach Susel, Project Director )
Study ID Numbers:	Rep2952
Study First Received:	October 3, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00767390
Health Authority:	Israel: Ministry of Health

Keywords provided by Biosense Webster, Inc.:

ACL Patch Placement

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009