Toumaz Technology conducts clinical trial of Sensium-enabled
wireless body monitor
3 November 2009
Toumaz Technology Limited has announced that it has begun
clinical trials of its Sensium 'digital plaster' wireless body monitor.
The trial of the ultra-low power, ultra-small size body monitoring
system is being conducted by a specialist clinical research team at
Imperial College London.
The study, which is being funded by global healthcare corporation
CareFusion (a recent spin-out of Cardinal Health) and conducted at St
Mary’s Hospital (part of Imperial College Healthcare NHS Trust) is
expected to demonstrate the high quality physiological data that can be
continuously acquired by wireless, unobtrusive Sensium-enabled devices.
Initial results are expected by the end of December this year.
In the milestone trial, volunteers and patient groups will be
provided with a wearable Sensium digital 'plaster' or patch that can
continuously monitor multiple vital signs, including temperature, heart
rate and respiration.
The focus of the trial will be to verify that the physiological data
acquired by the digital plaster system within a clinical setting is
equivalent to that acquired using current gold-standard monitors in use
in hospitals — equipment that is often bulky, expensive and fixed, such
that patient mobility is impaired.
The Sensium digital plaster is wireless and unobtrusive, meaning that
patients can remain ambulatory in hospital while still being monitored.
This flexibility allows continuous vital sign monitoring to be extended
to patients who would not normally be monitored, thereby offering the
potential to increase patient safety.
The Sensium digital plaster is a disposable device with a working
lifetime of several days, after which the plaster is disposed of in the
appropriate waste receptacle.
The trial is being conducted in three phases, an initial phase with
non-patient volunteers followed by two patient study groups: patients
recovering from surgery, and patients with specific medical conditions
in the general wards.
The digital plaster is based on Toumaz’s new generation AMx
semiconductor IP platform, which enables Sensium wireless technology
that has been specifically designed for Medical body area networks (MBANs)
and non-intrusive physiological monitoring.
Sensium provides the complete wireless infrastructure to allow
healthcare providers to monitor the human body continuously, wirelessly
and intelligently and at low-cost, with the robustness and medical
compliance normally associated with considerably more expensive capital
equipment. Sensium technology has already been validated and CE marked
in Toumaz’s Life Pebble non-disposable body worn monitoring devices.
The Sensium digital plaster is targeted for use in clinical
monitoring applications such as acute care, general ward environments,
tele-care, chronic disease monitoring, and in care home settings. For
all these applications, disposability provides convenience, simplicity
and patient comfort while ensuring infection control is maintained to
the highest standards.
Powered by thin batteries, body-worn Sensium-enabled monitors deliver
clinical-quality data and intelligently integrate it into an electronic
medical record via a network built on Toumaz’s power-optimised wireless
operating and networking system, Nano Sensor Protocol (NSP).
Dr Stephen Brett, a Consultant in Intensive Care Medicine at Imperial
College Healthcare NHS Trust and an Honorary Senior Lecturer at Imperial
College London, who is leading the trial, explains: “This technology has
the potential to improve the capturing of patient’s vital signs within
all areas of the hospital — enabling key physiological data to be
acquired at an increased frequency, with the minimum of inconvenience to
patients, and without the requirement to connect patients to immobile
pieces of equipment.
"This raises the possibility of technology: improving hospital safety
systems; enhancing the efficiency of adding vital sign data to patient
records: and potentially freeing valuable nursing staff time for other
patient care responsibilities.”
Toumaz Technology Co-Founder Keith Errey commented, “This is a very
significant step on the path towards pervasive deployment of Sensium-enabled
monitoring devices across a range of healthcare settings.
“Current patient data acquisition systems are mostly hospital-based,
expensive, generally wired, and non-mobile. Even so-called portable
equipment is still large, and prohibitively expensive for widespread
"Our Sensium technology platform is the step change that enables the
development of clinical grade yet low-cost and unobtrusive wireless body
monitoring solutions for the first time. We are tremendously excited
with the success so far of this important trial in partnership with
Imperial College London.”
Professor Chris Toumazou FRS, CEO and Founder of Toumaz Holdings, and
Director of the Institute of Biomedical Engineering at Imperial College
London, added: “It is fantastic to see the Sensium technology coming to
commercial fruition, and for us to be launching this study at Imperial
College Healthcare NHS Trust.
"This is a key stage in our commercial journey and one that opens the
door to some very exciting applications of our technology in clinical
environments next year.
“The business case is simple: by using the disposable digital plaster
to monitor on a 24-7 basis, critical medical information can be
monitored that would not otherwise have been detected. This preventative
form of medicine will mean that less people could require intensive care
in the future, saving lives and at the same time providing greater
efficiencies and cost savings to the NHS. Once proven in a hospital
setting then the digital plaster can be deployed in the home in the same