Bruin Biometrics conducts trials to detect pressure ulcers with the SEM Scanner

Thursday, December 5, 2013 10:36 AM

Bruin Biometrics (BBI) has announced results from two IRB-approved clinical trials conducted with the SEM Scanner, a Class IIA medical device that is intended to detect localized tissue edema and pressure induced tissue damage which may lead to the formation of pressure ulcers.

BBI enrolled 31 healthy subjects in a pilot study conducted in Los Angeles, Calif. to assess the reliability of the SEM Scanner. Results indicate that the SEM Scanner gives consistent readings and is reliable across different users and across different device models.

BBI also sponsored an investigational, non-significant risk study to collect data needed to analyze SEM Scanner readings at the University of Massachusetts Memorial Medical Center in Worcester, Massachusetts. Fifty subjects from the adult Critical Care Unit were enrolled in the trial and followed for five days. Although the medical center reports annual pressure ulcer incidence of 5.08%, zero subjects developed a pressure ulcer during the course of the BBI trial. Analysis of trial data is underway, and a final study report is expected in early 2014.

BBI will sponsor additional trials throughout 2014. The first will take place in the U.S. and will evaluate SEM Scanner readings in subjects with known pressure ulcers. A second study will enroll subjects throughout the U.S. and Europe in order to evaluate the SEM Scanner's effectiveness in lowering the incidence of pressure ulcers against the current standard of care.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

November 17

PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

ERT acquires eClinical Insights in "strategic combination" to gain cloud-based trial software platform, expertise

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs