- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01545973
Understanding the Physiological Implications of Scanning Kelvin Probe Measurements
March 2, 2012 updated by: Andrew A. Ahn, Massachusetts General Hospital
Measuring Skin Electrical Potential With the Kelvin Probe: Underlying Physiology
The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Charlestown, Massachusetts, United States, 02129
- Massachusetts General Hospital - Martinos Center for Biomedical Imaging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy Volunteers
Description
Inclusion Criteria:
- "Healthy" is defined as not having a chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)
Exclusion Criteria:
- autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Volunteers
Human subjects without chronic medical conditions, defined as conditions requiring chronic medication use.
|
Application of normal saline to skin and Tape stripping of the superficial skin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surface Electrical Potential
Time Frame: 1 day
|
The electrical potential of skin obtained from the Scanning Kelvin Probe
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electrical Impedance
Time Frame: One day
|
Electrical impedance (measurement) obtained through another, more conventional measurement device.
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
August 1, 2012
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
March 2, 2012
First Submitted That Met QC Criteria
March 2, 2012
First Posted (Estimate)
March 7, 2012
Study Record Updates
Last Update Posted (Estimate)
March 7, 2012
Last Update Submitted That Met QC Criteria
March 2, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 55R21AT005249-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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