Pressure UlcerCaPASNCT01857089
Characterization of Sitting Postures in Healthy Subjects
A study testing Orthotest CE in people with Pressure Ulcer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Orthotest CE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Aug 2013
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- more or equal than 18 years old
- age between 20 and 30 years old
- affiliation to social security or similarly regime
Who cannot join
- Person with pacemaker
- Person with a history of lumbar pain, chest or/and cervical pain.
- Person with an history of lumbar, chest or/and cervical muscular disorders,
- Person with history of circulatory problems,
- Person with history of skin pathologies at the seat area,
- Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
- Person having a total annual compensation for the participation in biomedical research higher than €4460.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.
Read the detailed description
- The purpose of this study is to understand the formation of pressure sore, to improve the care of paraplegic patients.
- This pilot study is going to help to establish a model in healthy volunteers in the prevention of pressure sores.
- Conditions
- Pressure Ulcer
- Being tested
- Orthotest CE
- Keywords
- Pressure Ulcer, prevention
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthotest CEDevice
Also called Orthotest CE mark, Vista-Medical, Mapping system
Orthotest CE is a rigid base mapping system composed by 1024 pressure transducers uniformly distributed in a 35x35 cm surface.
Orthotest CE is a product manufactured by Vista-Medical. The patient sit on the rigid base during 2 hours to record the pressure and all the data needed for the pilot study.
Pressure measurement
| Study group | Role | What they receive |
|---|---|---|
| Pressure Measurement | Experimental | Not described Receives: Device: Orthotest CE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included.
Sit pressure measurements of all subjects of the study
Measured: 2 hours
Secondary outcomes (1)
Correlation between interface pressure measurements and postural data.
- Sit pressure measurements
- Video recording
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre MOREAU-GAUDRY, MD,PhD, Principal investigator, INSERM-CIC-IT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857089
- Sponsor's protocol ID
- CaPAS-DCIC-1204
- Acronym
- CaPAS
- Status last verified
- Apr 2014
- First submitted
- 1 Feb 2013
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Sitting Postures in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01857089
- Acronym / sponsor ID
- CaPAS / CaPAS-DCIC-1204
- Conditions
- Pressure Ulcer
- Keywords
- Pressure Ulcer, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 May 2013 (estimated)
- 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 aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.
Detailed description
- The purpose of this study is to understand the formation of pressure sore, to improve the care of paraplegic patients.
- This pilot study is going to help to establish a model in healthy volunteers in the prevention of pressure sores.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure Measurement | Experimental | Device: Orthotest CE |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- more or equal than 18 years old
- age between 20 and 30 years old
- affiliation to social security or similarly regime
Key exclusion criteria (7 listed)
- Person with pacemaker
- Person with a history of lumbar pain, chest or/and cervical pain.
- Person with an history of lumbar, chest or/and cervical muscular disorders,
- Person with history of circulatory problems,
- Person with history of skin pathologies at the seat area,
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 |
|---|---|---|
| Orthotest CEAlso: Orthotest CE mark, Vista-Medical, Mapping systemOrthotest CE is a rigid base mapping system composed by 1024 pressure transducers uniformly distributed in a 35x35 cm surface. Orthotest CE is a product manufactured by Vista-Medical. The patient sit on the rigid base during 2 hours to record the pressure and all the data needed for the pilot study. Pressure measurement | Device | Pressure Measurement |
Primary outcome
Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included.
Time frame: 2 hours
Sit pressure measurements of all subjects of the study
1 secondary outcome
Correlation between interface pressure measurements and postural data.
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Related InfoLink provided by the sponsor.
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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.
Alexandre MOREAU-GAUDRY, MD,PhD principal investigator
INSERM-CIC-IT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthotest CE in people with Pressure Ulcer, run by University Hospital, Grenoble 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 11 Apr 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included. (time frame: 2 hours). 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 11 Apr 2014.