ResApp has announced the final site and received the final IRB approval for its Smartcough-C trial. Texas Children's Hospital will join the previously announced Massachusetts General Hospital and Cleveland Clinic in a three-site trial of the Australian company's ResAppDx app, which essentially uses the smartphone microphone as a stethoscope to listen to a patient’s breathing.
The double-blind study will have diagnosis of pneumonia as a primary endpoint. The secondary endpoints will include diagnosis of upper respiratory tract infection, croup, bronchiolitis and asthma.
Dr. Esther Maria Sampayo, assistant professor of pediatric emergency medicine at Baylor College of Medicine, will be the principal investigator at Texas Children's. As previously announced, Dr. John Carl, director of the Center for Pediatric Pulmonary Medicine, will be the principal investigator at Cleveland Clinic.
Rather than relying solely on a doctor’s ears to form a diagnosis from the sounds ResAppDx records, the company has been developing machine-learning algorithms that will automatically determine which respiratory condition a patient might have, including pneumonia, asthma, bronchiolitis and COPD. Eventually, the company hopes to integrate those algorithms into telehealth offerings as well as making them available for clinical use. However in order to do that the company needs to secure de novo FDA clearance, and this multi-site double-blind trial will help establish some of the evidence for that clearance, the company hopes.
The evidence the company has amassed so far is promising. Back in April, ResApp achieved an accuracy of 89 percent in a clinical study of 524 pediatric patients conducted by the company at Joondalup Health Campus (JHC) and Princess Margaret Hospital (PMH) in Perth, Western Australia, where the company is based. In a smaller trial of 243 adult patients, also at Joondalup, the company saw accuracy between 91 and 100 percent.