CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 112 enrolled
Drug / intervention
ODI-Tech medical devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05608798
NCT05608798N/ACompleted
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Microscopic and Spectroscopic Examination of Skin Microcirculation in Healthy Individuals Using ODI Technology

ODI Medical AS·interventional·Posted Nov 8, 2022·Updated Apr 3, 2024

In Brief

A clinical study evaluating ODI-Tech medical device for Healthy. Completed, enrolled 112 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNorway
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 8, 2022
Enrollment StartSep 20, 2022
Primary CompletionDec 22, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.6 years ago

Interventions

ODI-Tech medical devicedevice

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.