CARTO 3 Human Patch Study

This study has suspended participant recruitment.
(The required results were obtained through alternate methodology)
Sponsor:
Information provided by:
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00767390
First received: October 3, 2008
Last updated: November 20, 2008
Last verified: November 2008

October 3, 2008
November 20, 2008
October 2008
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00767390 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy Volunteers

Healthy
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
44
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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
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00767390
Rep2952
No
Pesach Susel, Project Director, Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Principal Investigator: Giris Jacob, M.D. Rambam Health Care Campus
Biosense Webster, Inc.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP