Understanding the Physiological Implications of Scanning Kelvin Probe Measurements
| Tracking Information | |||||
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| First Received Date ICMJE | March 2, 2012 | ||||
| Last Updated Date | March 2, 2012 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Surface Electrical Potential [ Time Frame: 1 day ] [ Designated as safety issue: No ] The electrical potential of skin obtained from the Scanning Kelvin Probe |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Electrical Impedance [ Time Frame: One day ] [ Designated as safety issue: No ] Electrical impedance (measurement) obtained through another, more conventional measurement device. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Understanding the Physiological Implications of Scanning Kelvin Probe Measurements | ||||
| Official Title ICMJE | Measuring Skin Electrical Potential With the Kelvin Probe: Underlying Physiology | ||||
| Brief Summary | The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements. |
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| Detailed Description | The Scanning Kelvin Probe measures the electrical potential of material surfaces without actually touching it. Although this technology has been applied to non-living materials (e.g. metal and semiconductors) before, it has not been effectively applied to biological materials, much less to live human skin . This project aims to evaluate the use of Scanning Kelvin Probe to live human skin by investigating the effects of skin thickness, skin moisture, and sweat glands on Kelvin Probe measurements of electrical potential. Testing will be performed on the arms and hands of twenty four healthy individuals under different study conditions. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole Blood |
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| Sampling Method | Probability Sample | ||||
| Study Population | Healthy Volunteers |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Skin Moistening, Skin Denuding
Application of normal saline to skin and Tape stripping of the superficial skin |
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| Study Group/Cohort (s) | Healthy Volunteers
Human subjects without chronic medical conditions, defined as conditions requiring chronic medication use.
Intervention: Other: Skin Moistening, Skin Denuding |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01545973 | ||||
| Other Study ID Numbers ICMJE | 55R21AT005249-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Andrew A. Ahn, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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