CARTO 3 Human Patch Study (Human Patch)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00767390
Recruitment Status : Withdrawn (The required results were obtained through alternate methodology)
First Posted : October 7, 2008
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
Biosense Webster, Inc.

October 3, 2008
October 7, 2008
October 14, 2015
October 2008
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Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites. [ Time Frame: 6 hours ]
Same as current
Complete list of historical versions of study NCT00767390 on Archive Site
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CARTO 3 Human Patch Study
CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case
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.
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Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Healthy Volunteers
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.
ACL Patch
Intervention: Device: ACL Patch
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
20 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Biosense Webster, Inc.
Biosense Webster, Inc.
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Principal Investigator: Giris Jacob, M.D. Rambam Health Care Campus
Biosense Webster, Inc.
October 2015