ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, has introduced ERT SpiroSphere, the first and only spirometer designed specifically for use in global clinical trials. SpiroSphere efficiently captures research-grade clinical data that meet the most stringent regulatory requirements and ensures the highest quality data are immediately accessible by all clinical trial users.
Based on ERT’s decades of experience supporting more than 1,000 worldwide respiratory trials and extensive input from pharmaceutical sponsors and investigative sites, SpiroSphere’s advanced technology overcomes the challenges faced by site personnel that often impede the collection of precise clinical trial data.
According to the American Thoracic Society (ATS) and European Respiratory Society (ERS), improper pulmonary test performance is the largest source of subject variability for respiratory indications such as asthma, COPD and idiopathic pulmonary fibrosis (IPF). SpiroSphere optimizes data collection while reducing site burden through a pre-calibrated, patient-friendly pneumotach sensor combined with a cordless, compact, touch screen tablet providing freedom of movement and ease of use for both site personnel and patients. Automated, study-specific workflows guide users and patients to perform proper testing maneuvers through a series of intuitive on-screen instructions and test results in real-time to ensure the highest quality data are captured.
ERT SpiroSphere enables site personnel to maintain dual focus on both the patient and data quality: smart technology like the built-in biometric fingerprint scanner ensures only trained personnel can operate the device. As connectivity is enabled via built-in Wi‑Fi, Ethernet or mobile networks, test results are seamlessly uploaded to ERT’s EXPERT® platform for centralized review and insights, and program updates are deployed quickly and conveniently for sites.
“We worked closely with leading pharmaceutical companies, key opinion leaders and investigative sites to understand their specific needs and built the industry’s first spirometer designed with all clinical trial users in mind,” said Achim Schülke, Executive Vice President of Respiratory Solutions at ERT. “While other spirometers evolved for use in clinical trials after originating as healthcare devices, SpiroSphere was purpose-built using the latest technology to deliver highly precise, research-grade data. This enables clinical trial sponsors to confidently evaluate the efficacy and safety of novel medical treatments during clinical development.”
SpiroSphere has received the 510(k) marketing authorization by the FDA and is CE marked. For more information on SpiroSphere and ERT’s other respiratory solutions, visit https://www.ert.com/
