Preventive CareRELIASEMNCT04955106
Evaluation of the Sub Epidermal Moisture a Device for the Screening of Pressure Ulcer (RELIASEM)
A study testing SEM Scanner in people with Preventive Care, run by Arjo France at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventive Care
- What is being tested?
- SEM Scanner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18
- Taken the full-hospital care in physical and rehabilitation Medicine
- Patient affiliated with a social security scheme
- In the case of curatorship, patient have read the patient information document and given his consent free and informed, in the presence of his/her curator
- In the case of guardianship, legal representative have to had read the legal representative information document for major placed under legal protection (under guardianship) and given his consent free and informed for the person for whom he is responsible (if the patient is agree),
Who cannot join
- Patient who objected his opposition during the exam
- Patient who have one or more presure ulcer on at list one of the measuring area
- Patient who has had a lower limb amputation
- Pregnant, post natal period or breastfeeding women,
- Person deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pole Saint-Hélier
Rennes, Brittany Region, 35000
Philippe GALLIEN, Doctor, +33299295099, philippe.gallien@pole-sthelier.com
JEAN PAUL HAEBERLE, +33626742085, jean-paul.haeberle@arjo.com
About this study
Official title: Evaluation of the Relability and Validity of Device for the Screening of Early Pressure Ulcer in Hospitalization High-risk Patient, the Sub Epidermal Moisture During a Monocebtric Study
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
Read the detailed 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
- Conditions
- Preventive Care
- Being tested
- SEM Scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEM ScannerDiagnostic test
They will perform 2 sets of 3 measures (1 on sacrum, 1 on the right heel and 1 on the left heel)for each patients
| Study group | Role | What they receive |
|---|---|---|
| Sample for reliability | Other | Reliability and validity of SEM Scanner : intra rater, inter rater and inter novice/trained 8(2 trained rater, 2 novice rater, each one performed twice)measured will be performed on each patient. Receives: Diagnostic Test: SEM Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced)
We will calculate the intra-class correlation coefficient (ICC) intra- and inter-evaluator (experienced vs experienced)
Measured: immediately after the intervention
Evaluation of the validity of the SEM Scanner on at risk population
Intra-class correlation coefficient is the correlation coefficient between SEM Scanner measure and the norton scare
Measured: immediately after the intervention
Evaluation of the validity of the SEM Scanner on at risk population
The Norton scale will be used by the study :Norton ≥ 18 low or without risk, 14< Norton <18 medium risk, 12≤ Norton ≤14 high risk, Norton < 12 very high risk
Measured: During the evaluation 1 day assessed
Secondary outcomes (2)
valuation of the reliability of the SEM Scanner on a population at risk (experienced vs novice/ novice vs novice) will be calculated
The intra-class correlation coefficient (ICC) intra- and inter- evaluator (experienced vs novice/novice vs novice) will be calculated
Measured: immediately after the intervention
Receiver Operating Characteristics (ROC)curve: Area under the Curve (AUC)
AUC of the SEM Scanner for every cut of scores of the Norton score
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start22 Jun 2021
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The SEM Scanner is placed on three skin areas (left heel, right heel and sacrum). It measures the moisture of the subcutaneous tissues. If returns a figure wich induces a classification * negative = value \<0.6 no risk, the figure is displayed in green * positive = value ≥0.6 proven risk, the figure is displayed in orange For each patient 3 measurements will be performed. Two of them will have been trained in the use of the SEM Scanner, whereas the others will be novice
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arjo France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pôle Saint Hélier
- Responsible party
- Sponsor
- Investigators
- Philippe Gallien, Doctor, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955106
- Sponsor's protocol ID
- 2021-A00458-33
- Acronym
- RELIASEM
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relability and Validity of Device for the Screening of Early Pressure Ulcer in Hospitalization High-risk Patient, the Sub Epidermal Moisture During a Monocebtric Study
- ClinicalTrials.gov ID
- NCT04955106
- Acronym / sponsor ID
- RELIASEM / 2021-A00458-33
- Conditions
- Preventive Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Arjo FranceIndustry (pharma, biotech, devices)
- Collaborators
- Pôle Saint Hélier
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The SEM Scanner is placed on three skin areas (left heel, right heel and sacrum). It measures the moisture of the subcutaneous tissues. If returns a figure wich induces a classification * negative = value <0.6 no risk, the figure is displayed in green * positive = value ≥0.6 proven risk, the figure is displayed in orange For each patient 3 measurements will be performed. Two of them will have been trained in the use of the SEM Scanner, whereas the others will be novice
| Arm | Type | Receives |
|---|---|---|
| Sample for reliability | Other | Diagnostic Test: SEM ScannerReliability and validity of SEM Scanner : intra rater, inter rater and inter novice/trained 8(2 trained rater, 2 novice rater, each one performed twice)measured will be performed on each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged over 18
- Taken the full-hospital care in physical and rehabilitation Medicine
- Patient affiliated with a social security scheme
- In the case of curatorship, patient have read the patient information document and given his consent free and informed, in the presence of his/her curator
- In the case of guardianship, legal representative have to had read the legal representative information document for major placed under legal protection (under guardianship) and given his consent free and informed for the person for whom he is responsible (if the patient is agree),
Key exclusion criteria (5 listed)
- Patient who objected his opposition during the exam
- Patient who have one or more presure ulcer on at list one of the measuring area
- Patient who has had a lower limb amputation
- Pregnant, post natal period or breastfeeding women,
- Person deprived of liberty by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEM ScannerThey will perform 2 sets of 3 measures (1 on sacrum, 1 on the right heel and 1 on the left heel)for each patients | Diagnostic test | Sample for reliability |
Primary outcome
Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced)
Time frame: immediately after the intervention
We will calculate the intra-class correlation coefficient (ICC) intra- and inter-evaluator (experienced vs experienced)
Evaluation of the validity of the SEM Scanner on at risk population
Time frame: immediately after the intervention
Intra-class correlation coefficient is the correlation coefficient between SEM Scanner measure and the norton scare
Evaluation of the validity of the SEM Scanner on at risk population
Time frame: During the evaluation 1 day assessed
The Norton scale will be used by the study :Norton ≥ 18 low or without risk, 14< Norton <18 medium risk, 12≤ Norton ≤14 high risk, Norton < 12 very high risk
2 secondary outcomes
valuation of the reliability of the SEM Scanner on a population at risk (experienced vs novice/ novice vs novice) will be calculated
Time frame: immediately after the intervention
Receiver Operating Characteristics (ROC)curve: Area under the Curve (AUC)
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Gallien, Doctor principal investigator
Pôle Saint Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEM Scanner in people with Preventive Care, run by Arjo France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Gallien, Doctor (+33299295099, philippe.gallien@pole-Sthellier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced) (time frame: immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.