A Test of the Investigational SEM Scanner
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.
1 other identifier
observational
50
1 country
1
Brief 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. This will help with clinical interpretation of the numbers and readings this device will provide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 16, 2013
CompletedFirst Posted
Study publicly available on registry
October 18, 2013
CompletedDecember 24, 2013
October 1, 2013
1 month
October 16, 2013
December 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Descriptive statistic measurements
The endpoint for this study is the establishment of descriptive statistics around readings given by the SEM Scanner.
5 day study period
Eligibility Criteria
Intensive Care Units
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Emhoff, MD
UMass Memorial Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2013
First Posted
October 18, 2013
Study Start
September 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
December 24, 2013
Record last verified: 2013-10