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Non Invasive and Non-Contact Dual-modal Imaging Of Tissue Oxygenation and Vascular Reactivity Dynamic Imaging Of Tissue Metabolism and Vascular Function.

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ClinicalTrials.gov Identifier: NCT01573390
Recruitment Status : Active, not recruiting
First Posted : April 9, 2012
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
  1. Quantitative validation of non-contact oxygenation imaging by the CWC imaging system
  2. Quantitative validation of non-contact vascular function imaging by the CWC imaging system
  3. Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement

Condition or disease
Quantitative Validation of Imaging System

Detailed Description:
The hyperspectral imaging technique estimates cutaneous tissue oxygenation by illuminating tissue and detecting tissue reflectance at different wavelengths. One major advantage of hyperspectral imaging is non-invasive and non-contact detection of tissue functional properties. The dual-mode imaging system integrates hyperspectral and thermal imaging modalities for simultaneous assessment of cutaneous tissue oxygenation and vascular function. This clinical protocol is defined to validate the CWC system on healthy human subjects

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Non Invasive and Non-Contact Dual-modal Imaging Of Tissue Oxygenation and Vascular Reactivity Dynamic Imaging Of Tissue Metabolism and Vascular Function.
Study Start Date : August 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Healthy participants.


Outcome Measures

Primary Outcome Measures :
  1. Non-Contact Oxygenation Imagiing [ Time Frame: 1 year ]
    Quantitative validation of non-contact oxygenation imaging by the CWC imaging system

  2. Non-Contact Vascular Function Imaging [ Time Frame: 1 year ]
    Quantitative validation of non-contact vascular function imaging by the CWC imaging system


Secondary Outcome Measures :
  1. Clinical usability for Comprehensive Wound Centers [ Time Frame: 1 year ]
    Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement.


Biospecimen Retention:   None Retained
there is no biospecimen collection require in this protocol.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Interested healthy volunteers
Criteria

Inclusion Criteria:

  • Adult 18 years and older
  • No history of diabetes.
  • No history of vascular disease

Exclusion Criteria:

  • Under 18 years of age
  • Unable to provide informed consent
  • Prisoners
  • Current smoker
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573390


Locations
United States, Ohio
The Ohio State University.
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Chandan K Sen
Investigators
Principal Investigator: Chandan K Sen, Ph.D. Ohio State University
More Information

Publications:

Responsible Party: Chandan K Sen, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01573390     History of Changes
Other Study ID Numbers: 2010H0017
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Chandan K Sen, The Ohio State University:
Non-invasive
tissue-oxygenation
hyperspectral
CWC imaging system