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NCT00767390 Clinical Trial

CARTO 3 Human Patch Study

Healthy Clinical Trial

— Human Patch  

Official title:
CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00767390
Other study ID # Rep2952
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received October 3, 2008
Last updated October 12, 2015
Start date October 2008

Study information
Verified date October 2015
Source Biosense Webster, Inc.
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Biosense Webster, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites. 6 hours Yes
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