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
  Purpose

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 Intervention Phase
Healthy
Device: ACL Patch
Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case

Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: October 2008
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767390

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

No publications provided

Responsible Party: Pesach Susel, Project Director, Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00767390     History of Changes
Other Study ID Numbers: Rep2952
Study First Received: October 3, 2008
Last Updated: November 20, 2008
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 16, 2014