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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01399879
Other study ID # 5R21AT005249
Secondary ID
Status Completed
Phase N/A
First received March 25, 2011
Last updated July 20, 2011
Start date September 2010
Est. completion date February 2011

Study information

Verified date July 2011
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The Scanning Kelvin Probe measures surface electrical potential without actually touching the skin. This is a pilot study to evaluate methods of minimizing noise during Scanning Kelvin Probe measurements. This project will focus specifically on noise arising from physical movement and environmental electrical field.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age greater than 18 years

Exclusion Criteria:

- chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)

- movement disorders/tremors

- extensive scars on the hand

- latex-allergies

- cardiac implantation, metallic joint/bone replacements (defibrillator or pacemaker)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Faraday cage, movement stabilization
The Faraday cage is a copper-mesh cage that surrounds the device and test site. It helps eliminate surrounding electrical noise. Movement stabilization will be achieved by placing a velcro strap over the arm to minimize random movements.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Variability in surface electrical potential measurements This study focuses on the ability of the Kelvin Probe to measure skin electrical potential. Because it does so without touching the skin, it is prone to noise - specifically physical movement and surrounding electrical noise. The variability in surface electrical potential is a way to determine how stable the measurements are. It can be determined immediately after testing - and will be used in data analyses (comparing across study volunteers) approximately 24 weeks after testing is complete. Within 24 hours of testing No
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