Clario, a healthcare research technology company that delivers leading endpoint technology solutions for clinical trials, announced a partnership with Strados Labs to provide the FDA-cleared RESP Biosensor for clinical trials. This innovative, wearable device is lightweight, comfortable and non-invasive, with capabilities that have not previously existed on the market, such as allowing for objective assessment of crackles, rhonchi, and wheeze events, as well as offering a streamlined approach for at-home cough monitoring in trial participants.
The Strados RESP Biosensor is a refreshingly modern, patient-centered solution for Clario’s customers looking at additional respiratory data endpoints. The wireless device records pulmonary sounds for 24 uninterrupted hours and has the capacity to hold up to 220 hours of recordings on board. With the capabilities of a digital stethoscope, this device can capture lung sounds, enabling measurement of cough frequency, cough severity, cough type, and other adventitious events.
“Clario has helped many sponsors to obtain high quality data supporting numerous drug approvals in respiratory clinical trials, and some of our customers are increasingly looking for robust and objective cough metrics – an endpoint that Strados Labs‘ RESP Biosensor addresses fantastically. The RESP Biosensor’s capabilities eliminate the need for subjective self-reporting and introduce several new respiratory endpoints enabling sponsors to now demonstrate drug efficacy from different angles, enabling greater flexibility in protocol design while reducing the burden for clinical sites and patients.” Achim Schülke, Chief Innovation Officer at Clario.
The RESP Biosensor’s design reduces the burden placed on the patient in the at-home environment. Weighing only as much as a pen and less than half an inch thick, patients can discreetly wear the device on their chest under their clothes and carry on with their day as they ordinarily would. The device is wireless and rechargeable, so there is no need for messy cables or battery replacements.
After 24 hours of continuous recording, the patient docks the RESPBiosensor on the charger, and while it charges, the recorded audio is transferred to the Strados Clinician Portal for review via the Clario-supplied mobile device.
SOURCE: PR Newswire