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Clinical Trial Summary

The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician


Clinical Trial Description

The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician. The study "RELIASEM" will study hospitalized patients with high risk of Pressure Injurieswith the next conditions: For each patient 14 mesures: 6 on the sacrum, 4 on the right heel and 4 on the left heel. This set of measure will be realized 2 timesby 4 different evaluator. To will have been trained in the use of the SEM Scanner where as the other will be novice. The main objective of this study is to determine on a risk population the intra- and inter-examiner reliability of the SEM Scanner ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04955106
Study type Interventional
Source Arjo France
Contact Philippe Gallien, Doctor
Phone +33299295099
Email philippe.gallien@pole-Sthellier.com
Status Recruiting
Phase N/A
Start date June 22, 2021
Completion date December 2021

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