Pressure UlcersNCT01965444
A Test of the Investigational SEM Scanner
An observational study of Pressure Ulcers, run by Bruin Biometrics, LLC at 1 site in United States.
Trial summary
The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2013
- Phase
- Observational
- 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
Study population: Intensive Care Units
Who may be able to join
- Subjects are 18 years of age or older.
- Subject or health care proxy is willing and able to provide informed consent for enrollment.
- Subject is agreeable to having skin assessments, blanchability tests, and SEM Scanner readings performed daily at all anatomical sites for a duration of five (5) days, with photography as needed.
- Subject is admitted to an intensive Care Unit (ICU) and has an anticipated ICU course of 48 hours or greater.
- Subject is not Comfort Measures Only (CMO).
- Subject is anticipated to be bedridden for ore than 6 hours per day.
- All four (4) of the subject's anatomical sites in question (sternum, sacrum, left heel and right heel) are accessible for scanning (e.g., no cast or medical device present such that heels are not accessible).
Who cannot join
- Subject has broken skin or scar tissue at the sternum, sacrum, left heel or right heel.
- Subjects for whom the physical act of performing the inspections and measurements required in this study are contra-indicated, as determined by the principal investigator or attending physician.
- Subjects or legal representatives who are unable to understand the aims and objectives of the trial.
- Presence of any condition(s) which seriously compromise(s) the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
- Subject is pregnant.
- Subject is incarcerated.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: An Investigational, Non-significant Risk Study to Collect Data Needed to Analyze Readings Given by the SEM Scanner Point of Care 200 Series (SEM POC 200) and Its Ability to Detect Sub Epidermal Moisture.
The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. This will help with clinical interpretation of the numbers and readings this device will provide.
- Conditions
- Pressure Ulcers
- Keywords
- Sub-epidermal moisture, Pressure Ulcers
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistic measurements
The endpoint for this study is the establishment of descriptive statistics around readings given by the SEM Scanner.
Measured: 5 day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruin Biometrics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Emhoff, MD, Principal investigator, UMass Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965444
- Sponsor's protocol ID
- SEM200-001
- Status last verified
- Oct 2013
- First submitted
- 16 Oct 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational, Non-significant Risk Study to Collect Data Needed to Analyze Readings Given by the SEM Scanner Point of Care 200 Series (SEM POC 200) and Its Ability to Detect Sub Epidermal Moisture.
- ClinicalTrials.gov ID
- NCT01965444
- Acronym / sponsor ID
- SEM200-001
- Conditions
- Pressure Ulcers
- Keywords
- Sub-epidermal moisture, Pressure Ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bruin Biometrics, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Oct 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 objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. This will help with clinical interpretation of the numbers and readings this device will provide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive Care Units
Key inclusion criteria (7 listed)
- Subjects are 18 years of age or older.
- Subject or health care proxy is willing and able to provide informed consent for enrollment.
- Subject is agreeable to having skin assessments, blanchability tests, and SEM Scanner readings performed daily at all anatomical sites for a duration of five (5) days, with photography as needed.
- Subject is admitted to an intensive Care Unit (ICU) and has an anticipated ICU course of 48 hours or greater.
- Subject is not Comfort Measures Only (CMO).
Key exclusion criteria (6 listed)
- Subject has broken skin or scar tissue at the sternum, sacrum, left heel or right heel.
- Subjects for whom the physical act of performing the inspections and measurements required in this study are contra-indicated, as determined by the principal investigator or attending physician.
- Subjects or legal representatives who are unable to understand the aims and objectives of the trial.
- Presence of any condition(s) which seriously compromise(s) the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
- Subject is pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive statistic measurements
Time frame: 5 day study period
The endpoint for this study is the establishment of descriptive statistics around readings given by the SEM Scanner.
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 24 Dec 2013.
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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.
Timothy Emhoff, MD principal investigator
UMass Memorial Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcers, run by Bruin Biometrics, LLC at 1 site in United States.
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 7 inclusion and 6 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 24 Dec 2013. 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 United States. 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?
Descriptive statistic measurements (time frame: 5 day study period). 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 24 Dec 2013.