NCT05608798

Healthy Volunteer Study to Assess Microcirculatory Function

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: ODI Medical AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-09-20
• Primary completion: 2023-12-22
• Completion: 2023-12-22
• First posted: 2022-11-08
• Last updated: 2024-04-03

Locations

1 site across 1 country: Norway