CARTO 3 Human Patch Study

NCT ID: NCT00767390

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ACL Patch

ACL Patch

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giris Jacob, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Other Identifiers

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Rep2952

Identifier Type: -

Identifier Source: org_study_id

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