A Test of the Investigational SEM Scanner

Pressure Ulcers Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965444
• Other study ID #: SEM200-001
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: December 23, 2013
• Start date: September 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Bruin Biometrics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. This will help with clinical interpretation of the numbers and readings this device will provide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bruin Biometrics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No