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Completed

NCT Number: NCT05608798

Healthy Volunteer Study to Assess Microcirculatory Function

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)

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ODI Medical

Oslo, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ODI-Tech medical device

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.

Primary outcomes

  1. Functional Capillary Density (FCD)

    Time frame: Day 1, 2 assessments, minimum 1 hour between

    Expressed as mean value

  2. Heterogeneity of FCD

    Time frame: Day 1, 2 assessments, minimum 1 hour between

    FCD from each frame is recorded from four quadrants in each frame where the coefficient of variation (CoV) in each frame is calculated, as well as an average CoV based on the 20 values from the same subject and session.

  3. Microvascular Oxygen Saturation (SmvO2)

    Time frame: Day 1, 2 assessments, minimum 1 hour between

    Percent

  4. Heterogeneity of SmvO2

    Time frame: Day 1, 2 assessments, minimum 1 hour between

    [coefficient of variation] within the specific assessment and patient

  5. Tissue haematocrit (TH)

    Time frame: Day 1, 2 assessments, minimum 1 hour between

    Percentage

  6. Heterogeneity of TH

    Time frame: Day 1, 2 assessments, minimum 1 hour between

    [coefficient of variation] within the specific assessment and patient

  7. Visual assessment of capillary morphology

    Time frame: Day 1, 2 assessments, minimum 1 hour between

    dilatation, elongation, microvascular bleedings

Secondary outcomes

  1. Incidence of AE/ADE/SAE/SADE/DD

    Time frame: Day 1

    Descriptive as number of reported, graded

  2. Reproducibility

    Time frame: Day 1

    Variance of FCD, SmvO2 and its associated heterogeneity between measurements

Sponsors and collaborators

Lead sponsor

ODI Medical AS

Industry

Registry information

Official study title

Microscopic and Spectroscopic Examination of Skin Microcirculation in Healthy Individuals Using ODI Technology

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2022
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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