Healthy Volunteer Study to Assess Microcirculatory Function

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: ODI-Tech medical device

• Registration Number: NCT05608798
• Lead Sponsor: ODI Medical AS

Brief Summary

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)

Detailed 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

Study Timeline

• Study Start: 2022-09-20
• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Primary Completion: 2023-12-22
• Study Completion: 2023-12-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Examination with the ODI-Tech medical device	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.

Primary Outcome Measures

Name	Time	Method
Tissue haematocrit (TH)	Day 1, 2 assessments, minimum 1 hour between	Percentage
Heterogeneity of TH	Day 1, 2 assessments, minimum 1 hour between	\[coefficient of variation\] within the specific assessment and patient
Microvascular Oxygen Saturation (SmvO2)	Day 1, 2 assessments, minimum 1 hour between	Percent
Functional Capillary Density (FCD)	Day 1, 2 assessments, minimum 1 hour between	Expressed as mean value
Heterogeneity of FCD	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.
Heterogeneity of SmvO2	Day 1, 2 assessments, minimum 1 hour between	\[coefficient of variation\] within the specific assessment and patient
Visual assessment of capillary morphology	Day 1, 2 assessments, minimum 1 hour between	dilatation, elongation, microvascular bleedings

Secondary Outcome Measures

Name	Time	Method
Reproducibility	Day 1	Variance of FCD, SmvO2 and its associated heterogeneity between measurements
Incidence of AE/ADE/SAE/SADE/DD	Day 1	Descriptive as number of reported, graded

Trial Locations

Locations (1)

ODI Medical; 🇳🇴 Oslo, Norway