Healthy Volunteer Study to Assess Microcirculatory Function
NCT ID: NCT05608798
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2022-09-20
2023-12-22
Brief Summary
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Detailed Description
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• Obtain reference data of the studied microvascular parameters in a healthy, heterogeneous population
Secondary objectives:
* Determine the reproducibility of the parameters obtained using the device produced by ODI Medical
* Confirm the safety of the device produced by ODI Medical
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Examination with the ODI-Tech medical device
Diffuse reflectance spectroscopy (DRS) operating within the visible wavelength region will be used for the microvascular oxygen saturation and haematocrit measurements.
Computer-assisted microscopy (CAM) will be used for recording frames of skin microcirculation.
ODI-Tech medical device
The device captures and stores frames of the movement of blood in capillaries and spectra containing information on oxygen saturation. Proprietary software is used to analyse the obtained frames and spectra to calculate microvascular parameters such as functional capillary density and microvascular oxygen saturation.
ODI-Tech can be brought to the patient's bedside and operates non-invasively. The device parts are in contact with the patient for less than 5 minutes.
Interventions
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ODI-Tech medical device
The device captures and stores frames of the movement of blood in capillaries and spectra containing information on oxygen saturation. Proprietary software is used to analyse the obtained frames and spectra to calculate microvascular parameters such as functional capillary density and microvascular oxygen saturation.
ODI-Tech can be brought to the patient's bedside and operates non-invasively. The device parts are in contact with the patient for less than 5 minutes.
Eligibility Criteria
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Inclusion Criteria
* Subjects without signs or symptoms of acute or chronic disease and that are not treated with regular medication (contraceptive pills/IUD and oestrogen medication for menopausal symptoms are allowed). Pregnant women can be included.
Exclusion Criteria
* Misusers of alcohol
* Misusers of drugs
* Not intact skin or reddening in the region of interest
18 Years
ALL
Yes
Sponsors
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ODI Medical AS
INDUSTRY
Responsible Party
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Principal Investigators
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Knut Kvernebo, PhD, MD
Role: STUDY_CHAIR
ODI Medical
Locations
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ODI Medical
Oslo, , Norway
Countries
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References
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Sundheim LK, Sporastoyl AH, Wester T, Salerud G, Kvernebo K. Acute skin trauma induces hyperemia, but superficial papillary nutritive perfusion remains unchanged. Microcirculation. 2017 Oct;24(7). doi: 10.1111/micc.12389.
Fredly S, Fugelseth D, Nygaard CS, Salerud EG, Stiris T, Kvernebo K. Noninvasive assessments of oxygen delivery from the microcirculation to skin in hypothermia-treated asphyxiated newborn infants. Pediatr Res. 2016 Jun;79(6):902-6. doi: 10.1038/pr.2016.16. Epub 2016 Feb 8.
Mork C, Salerud EG, Asker CL, Kvernebo K. The prostaglandin E1 analog misoprostol reduces symptoms and microvascular arteriovenous shunting in erythromelalgia-a double-blind, crossover, placebo-compared study. J Invest Dermatol. 2004 Mar;122(3):587-93. doi: 10.1111/j.0022-202X.2004.22339.x.
Wester T, Awan ZA, Kvernebo TS, Salerud G, Kvernebo K. Skin microvascular morphology and hemodynamics during treatment with veno-arterial extra-corporeal membrane oxygenation. Clin Hemorheol Microcirc. 2014;56(2):119-31. doi: 10.3233/CH-131670.
Mork C, Kvernebo K, Asker CL, Salerud EG. Reduced skin capillary density during attacks of erythromelalgia implies arteriovenous shunting as pathogenetic mechanism. J Invest Dermatol. 2002 Oct;119(4):949-53. doi: 10.1046/j.1523-1747.2002.00218.x.
Mork C, Asker CL, Salerud EG, Kvernebo K. Microvascular arteriovenous shunting is a probable pathogenetic mechanism in erythromelalgia. J Invest Dermatol. 2000 Apr;114(4):643-6. doi: 10.1046/j.1523-1747.2000.00944.x.
Staxrud LE, Jakobsson A, Kvernebo K, Salerud EG. Spatial and temporal evaluation of locally induced skin trauma recorded with laser Doppler techniques. Microvasc Res. 1996 Jan;51(1):69-79. doi: 10.1006/mvre.1996.0008.
Bungum L, Kvernebo K, Oian P, Maltau JM. Laser doppler-recorded reactive hyperaemia in the forearm skin during the menstrual cycle. Br J Obstet Gynaecol. 1996 Jan;103(1):70-5. doi: 10.1111/j.1471-0528.1996.tb09517.x.
Fredly S, Fugelseth D, Wester T, Haggblad E, Kvernebo K. Skin microcirculation in healthy term newborn infants--assessment of morphology, perfusion and oxygenation. Clin Hemorheol Microcirc. 2015;59(4):309-22. doi: 10.3233/CH-131764.
Awan ZA, Haggblad E, Wester T, Kvernebo MS, Halvorsen PS, Kvernebo K. Diffuse reflectance spectroscopy: Systemic and microvascular oxygen saturation is linearly correlated and hypoxia leads to increased spatial heterogeneity of microvascular saturation. Microvasc Res. 2011 May;81(3):245-51. doi: 10.1016/j.mvr.2011.02.004. Epub 2011 Mar 2.
Kvernebo AK, Miyamoto T, Sporastoyl AH, Wikslund LK, Masoy SE, Drolsum L, Moe MC, Salerud G, Fukamachi K, Kvernebo K. Quantification of ocular surface microcirculation by computer assisted video microscopy and diffuse reflectance spectroscopy. Exp Eye Res. 2020 Dec;201:108312. doi: 10.1016/j.exer.2020.108312. Epub 2020 Oct 22.
Other Identifiers
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CIV-NO-22-08-040389
Identifier Type: -
Identifier Source: org_study_id
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