Boston clinical trials
Northern Ireland Company Intelesens today announced the commencement of a world-first clinical trial to evaluate one of their devices at Massachusetts General Hospital (MGH) and Spaulding Rehabilitation Hospital in Boston, USA. The company has developed a unique body-worn, non-invasive, wireless, vital signs sensor, Aingeal, which is attached via an adhesive electrode patch to a patient's torso and which measures ecg, heart rate, temperature, motion and, for the first time in an ambulatory patient, respiration rate. The device can be worn by the patient from admission at ER all through the patient's journey in hospital, up to discharge. The patient's vital signs are monitored continuously and sent to the hospital records system via their secure wi-fi network. The trials running through July are designed to test the sensor accuracy and to gather feedback on the wearability/usability of the Aingeal system. Patient vital signs will be tracked in three settings: the MGH Operating Room (OR), the MGH Sleep Lab and in the Spaulding cardio-pulmonary research centre.
The Intelesens team has been collaborating with The Sims Innovation Lab at Partners Healthcare and CIMIT (Center for the Integration of Medicine and Innovative Technology) under the leadership of Dr Nat Sims. The Boston team has worked through the device specification and development phase with Intelesens Project Leader and Senior Engineer David Branagh under the guidance of Intelesens's CTO Professor John Anderson. The development of the device has been supported by Invest Northern Ireland and CIMIT in Boston.
The results of the trials will be used as part of an FDA regulatory submission expected to approved by January 2011.