Non Invasive and Non-Contact Imaging Of Tissue Oxygenation and Vascular Reactivity

Quantitative Validation of Imaging System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01573390
• Other study ID #: 2010H0017
• Status: Withdrawn

Study information

• Verified date: April 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quantitative Validation of Imaging System

Locations

Country	Name	City	State
United States	The Ohio State University.	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Chandan K Sen

Country where clinical trial is conducted

United States, 

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Contact Oxygenation Imagiing	Quantitative validation of non-contact oxygenation imaging by the CWC imaging system	1 year
Primary	Non-Contact Vascular Function Imaging	Quantitative validation of non-contact vascular function imaging by the CWC imaging system	1 year
Secondary	Clinical usability for Comprehensive Wound Centers	Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement.	1 year