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CARTO 3 Human Patch Study (Human Patch)

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ClinicalTrials.gov Identifier: NCT00767390
Recruitment Status : Withdrawn (The required results were obtained through alternate methodology)
First Posted : October 7, 2008
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Device: ACL Patch Phase 1 Phase 2

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case
Study Start Date : October 2008
Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites. [ Time Frame: 6 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767390


Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Giris Jacob, M.D. Rambam Health Care Campus
More Information

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00767390     History of Changes
Other Study ID Numbers: Rep2952
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Biosense Webster, Inc.:
ACL Patch Placement