Healthy Volunteer Study to Assess Microcirculatory Function

ODI Medical

Status: Completed

Conditions: Healthy

Treatments: Device: ODI-Tech medical device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05608798

CIV-NO-22-08-040389

Details and patient eligibility

About

The aim of the study is to obtain microvascular data from a healthy, heterogeneous population for assessing reference values for the parameters Functional Capillary Density (FCD), heterogeneity of FCD, Microvascular Oxygen Saturation (SmvO2) and Heterogeneity of SmvO2 for healthy adults with respect to gender, age, and skin type (Fitzpatrick scale)

Full description

Primary objective:

• 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

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age >18
• 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

• Regular smokers
• Misusers of alcohol
• Misusers of drugs
• Not intact skin or reddening in the region of interest

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Examination with the ODI-Tech medical device

Other group

Description:

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.

Treatment:

Device: ODI-Tech medical device