iSpiro – Next generation respiratory home monitoring

Easy-to-use home Spirometry

Clario iSpiro^® collects full spirometry at home, enabling remote collection of pulmonary endpoints that are becoming increasingly important in clinical research. iSpiro is the combination of an easy-to-use spirometry sensor that meets American Thoracic Society / European Respiratory Society (ATS/ERS) requirements in conjunction with the iSpiro App and handheld device.

The iSpiro App is designed to both educate the patient and improve the quality of the spirometry data collected:

• Guides patient through the lung function assessment
• Includes easy-to-follow instructional videos and step-by-step instructions
• Provides on-screen test results, quality statements and feedback

The iSpiro App also reduces investigative site burden through a simplified patient-specific setup. QR codes generated through the Clario Portal and a quick setup checklist make deployment easy for sites and patients.

Mobile cellular communication networks seamlessly transfer collected data at any time, right after the test or at a scheduled time. This allows for near real-time review of collected data by the investigator or assigned reviewers via the Clario Portal.

Guided patient experience

The iSpiro application’s clean interface design helps the patient focus on their task at hand. Guided coaching and workflows ensure that they are aware of the steps to perform for high-quality spirometry performance at home.

Optimized data flow

Data is captured by iSpiro and automatically transferred to the Clario Portal without the need for patient or site interaction (integrated mobile cellular data transfer via the iSpiro App and handheld device).

Sites

• Easily dispense and reassign iSpiro via portal to patients
• Review reports of patient sessions in portal
• Receive email notifications when measured value falls below threshold or if patient session has not occurred in three consecutive days

Patients

• Easily collect spirometry with iSpiro in scheduled home sessions
• Transfer data collected at home to Clario

Sponsors

• Review collected data on Clario portal and reports
• Receive email notifications on transferred data
• Receive data exports from Clario

Quality and safety

Clario operates a Quality Management System according to EN IS0 13485 and 21 CFR Part 820. The availability of the iSpiro solution depends on national regulations and registrations. If the solution is available in your country, please contact Clario for more information.