Quantitative Validation of Imaging SystemNCT01573390
Non Invasive and Non-Contact Imaging Of Tissue Oxygenation and Vascular Reactivity
An observational study of Quantitative Validation of Imaging System, run by Chandan K Sen at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quantitative Validation of Imaging System
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Interested healthy volunteers
Who may be able to join
- Adult 18 years and older
- No history of diabetes.
- No history of vascular disease
Who cannot join
- Under 18 years of age
- Unable to provide informed consent
- Prisoners
- Current smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Invasive and Non-Contact Dual-modal Imaging Of Tissue Oxygenation and Vascular Reactivity Dynamic Imaging Of Tissue Metabolism and Vascular Function.
- Quantitative validation of non-contact oxygenation imaging by the CWC imaging system
- Quantitative validation of non-contact vascular function imaging by the CWC imaging system
- Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement
Read the 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
- Keywords
- Non-invasive, tissue-oxygenation, hyperspectral, CWC imaging system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Contact Oxygenation Imagiing
Quantitative validation of non-contact oxygenation imaging by the CWC imaging system
Measured: 1 year
Non-Contact Vascular Function Imaging
Quantitative validation of non-contact vascular function imaging by the CWC imaging system
Measured: 1 year
Secondary outcomes (1)
Clinical usability for Comprehensive Wound Centers
Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
Why it stopped: most of the study team left the institution prior to study initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Quantitative Validation of Imaging SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chandan K Sen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chandan K Sen, Ohio State University
- Investigators
- Chandan K Sen, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573390
- Sponsor's protocol ID
- 2010H0017
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2012
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu RX, Huang K, Qin R, Huang J, Xu JS, Ding L, Gnyawali US, Gordillo GM, Gnyawali SC, Sen CK. Dual-mode imaging of cutaneous tissue oxygenation and vascular function. J Vis Exp. 2010 Dec 8;(46):2095. doi: 10.3791/2095.
PubMed 21178967Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. doi: 10.1056/NEJM199909023411006. No abstract available.
PubMed 10471461Reiber GE. Diabetic foot care. Financial implications and practice guidelines. Diabetes Care. 1992 Mar;15 Suppl 1:29-31. doi: 10.2337/diacare.15.1.s29.
PubMed 1559416Broughton G 2nd, Janis JE, Attinger CE. Wound healing: an overview. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):1e-S-32e-S. doi: 10.1097/01.prs.0000222562.60260.f9.
PubMed 16801750Sen CK. Wound healing essentials: let there be oxygen. Wound Repair Regen. 2009 Jan-Feb;17(1):1-18. doi: 10.1111/j.1524-475X.2008.00436.x.
PubMed 19152646Leach RM, Treacher DF. Oxygen transport-2. Tissue hypoxia. BMJ. 1998 Nov 14;317(7169):1370-3. doi: 10.1136/bmj.317.7169.1370. No abstract available.
PubMed 9812940Treacher DF, Leach RM. Oxygen transport-1. Basic principles. BMJ. 1998 Nov 7;317(7168):1302-6. doi: 10.1136/bmj.317.7168.1302. No abstract available.
PubMed 9804723Chang N, Goodson WH 3rd, Gottrup F, Hunt TK. Direct measurement of wound and tissue oxygen tension in postoperative patients. Ann Surg. 1983 Apr;197(4):470-8. doi: 10.1097/00000658-198304000-00017.
PubMed 6830354Wilson DF. Oxygen dependent quenching of phosphorescence: a perspective. Adv Exp Med Biol. 1992;317:195-201. doi: 10.1007/978-1-4615-3428-0_20.
PubMed 1288127Griffiths JR, Robinson SP. The OxyLite: a fibre-optic oxygen sensor. Br J Radiol. 1999 Jul;72(859):627-30. doi: 10.1259/bjr.72.859.10624317. No abstract available.
PubMed 10624317Scheffler A, Rieger H. Clinical information content of transcutaneous oxymetry (tcpO2) in peripheral arterial occlusive disease (a review of the methodological and clinical literature with a special reference to critical limb ischaemia). Vasa. 1992;21(2):111-26.
PubMed 1621428Barker SJ, Tremper KK. Pulse oximetry: applications and limitations. Int Anesthesiol Clin. 1987 Fall;25(3):155-75. doi: 10.1097/00004311-198702530-00010.
PubMed 3323062Shah SA, Bachrach N, Spear SJ, Letbetter DS, Stone RA, Dhir R, Prichard JW, Brown HG, LaFramboise WA. Cutaneous wound analysis using hyperspectral imaging. Biotechniques. 2003 Feb;34(2):408-13. doi: 10.2144/03342pf01.
PubMed 12613264Zweier JL, Thompson-Gorman S, Kuppusamy P. Measurement of oxygen concentrations in the intact beating heart using electron paramagnetic resonance spectroscopy: a technique for measuring oxygen concentrations in situ. J Bioenerg Biomembr. 1991 Dec;23(6):855-71. doi: 10.1007/BF00786005.
PubMed 1663949Ogawa S, Lee TM, Kay AR, Tank DW. Brain magnetic resonance imaging with contrast dependent on blood oxygenation. Proc Natl Acad Sci U S A. 1990 Dec;87(24):9868-72. doi: 10.1073/pnas.87.24.9868.
PubMed 2124706
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive and Non-Contact Dual-modal Imaging Of Tissue Oxygenation and Vascular Reactivity Dynamic Imaging Of Tissue Metabolism and Vascular Function.
- ClinicalTrials.gov ID
- NCT01573390
- Acronym / sponsor ID
- 2010H0017
- Keywords
- Non-invasive, tissue-oxygenation, hyperspectral, CWC imaging system
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: most of the study team left the institution prior to study initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chandan K SenUniversity, hospital or other
- First posted
- 9 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Quantitative validation of non-contact oxygenation imaging by the CWC imaging system
- Quantitative validation of non-contact vascular function imaging by the CWC imaging system
- Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Interested healthy volunteers
Key inclusion criteria (3 listed)
- Adult 18 years and older
- No history of diabetes.
- No history of vascular disease
Key exclusion criteria (4 listed)
- Under 18 years of age
- Unable to provide informed consent
- Prisoners
- Current smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-Contact Oxygenation Imagiing
Time frame: 1 year
Quantitative validation of non-contact oxygenation imaging by the CWC imaging system
Non-Contact Vascular Function Imaging
Time frame: 1 year
Quantitative validation of non-contact vascular function imaging by the CWC imaging system
1 secondary outcome
Clinical usability for Comprehensive Wound Centers
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Results publication: PubMed 21178967Xu RX, Huang K, Qin R, Huang J, Xu JS, Ding L, Gnyawali US, Gordillo GM, Gnyawali SC, Sen CK. Dual-mode imaging of cutaneous tissue oxygenation and vascular function. J Vis Exp. 2010 Dec 8;(46):2095. doi: 10.3791/2095.
- Results publication: PubMed 10471461Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. doi: 10.1056/NEJM199909023411006. No abstract available.
- Results publication: PubMed 1559416Reiber GE. Diabetic foot care. Financial implications and practice guidelines. Diabetes Care. 1992 Mar;15 Suppl 1:29-31. doi: 10.2337/diacare.15.1.s29.
- Results publication: PubMed 16801750Broughton G 2nd, Janis JE, Attinger CE. Wound healing: an overview. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):1e-S-32e-S. doi: 10.1097/01.prs.0000222562.60260.f9.
- Results publication: PubMed 19152646Sen CK. Wound healing essentials: let there be oxygen. Wound Repair Regen. 2009 Jan-Feb;17(1):1-18. doi: 10.1111/j.1524-475X.2008.00436.x.
- Results publication: PubMed 9812940Leach RM, Treacher DF. Oxygen transport-2. Tissue hypoxia. BMJ. 1998 Nov 14;317(7169):1370-3. doi: 10.1136/bmj.317.7169.1370. No abstract available.
- Results publication: PubMed 9804723Treacher DF, Leach RM. Oxygen transport-1. Basic principles. BMJ. 1998 Nov 7;317(7168):1302-6. doi: 10.1136/bmj.317.7168.1302. No abstract available.
- Results publication: PubMed 6830354Chang N, Goodson WH 3rd, Gottrup F, Hunt TK. Direct measurement of wound and tissue oxygen tension in postoperative patients. Ann Surg. 1983 Apr;197(4):470-8. doi: 10.1097/00000658-198304000-00017.
- Results publication: PubMed 1288127Wilson DF. Oxygen dependent quenching of phosphorescence: a perspective. Adv Exp Med Biol. 1992;317:195-201. doi: 10.1007/978-1-4615-3428-0_20.
- Results publication: PubMed 10624317Griffiths JR, Robinson SP. The OxyLite: a fibre-optic oxygen sensor. Br J Radiol. 1999 Jul;72(859):627-30. doi: 10.1259/bjr.72.859.10624317. No abstract available.
- Results publication: PubMed 1621428Scheffler A, Rieger H. Clinical information content of transcutaneous oxymetry (tcpO2) in peripheral arterial occlusive disease (a review of the methodological and clinical literature with a special reference to critical limb ischaemia). Vasa. 1992;21(2):111-26.
- Results publication: PubMed 3323062Barker SJ, Tremper KK. Pulse oximetry: applications and limitations. Int Anesthesiol Clin. 1987 Fall;25(3):155-75. doi: 10.1097/00004311-198702530-00010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandan K Sen, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quantitative Validation of Imaging System, run by Chandan K Sen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Contact Oxygenation Imagiing (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01573390, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.