Skip to main content
OpenTrials
Completed

NCT Number: NCT01965444

A Test of the Investigational SEM Scanner

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pressure Ulcers Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bruin Biometrics, LLC

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 18, 2013
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.