OVERVIEW
Site-based spirometry
Clario supports spirometry for centralized, site-based clinical trials through integrated, turn-key solutions as well as advanced systems for complex workflows and diverse respiratory endpoints. Our solutions are supported with research-grade training, expert overread and a convenient portal for sites and sponsor to access real-time data on trial and patient progression. Clario also supports sponsors looking for low-cost paper-only or device-only options, enabling tailored solutions for each customer. All the services offered for site-based spirometry are also available for remote testing through our DCT options.
For which indications is spirometry testing performed?
Spirometry is assessed for a wide range of non-respiratory and respiratory conditions, including:
- Non-respiratory indications
- Chronic Obstructive Pulmonary Disease (COPD)
- Cystic Fibrosis (CF)
- Asthma
- Idiopathic Pulmonary Disease (IPD)
- Interstitial Lung Disease (ILD)
- Pulmonary vascular disease
- Neuromuscular disorders
SOLUTIONS FOR
Site-based spirometry
Clario SpiroSphere
SpiroSphere®
Turn-key, site-based spirometry solution
Clario’s proprietary SpiroSphere device was designed to simplify routine trials. This portable and lightweight device is fully wireless and enables convenient, on-site capture of all standard spirometry metrics.
Designed with extensive trial site feedback, the SpiroSphere device utilizes hygienic, single-use pneumotach tubes to optimize patient safety. Pre-calibrated and user-friendly, the device was also designed to improve patient data and protocol compliance. A built-in biometric fingerprint scanner ensures that only qualified clinicians are able to conduct testing, and an intelligent feedback system ensures that patient maneuvers meet ATS/ERS standards.
Full, high-resolution digital spirometry curves can be effortlessly uploaded to Clario’s EXPERT® platform directly from the SpiroSphere device. Clario reviews data for consistency and plausibility, alerting the sponsor of potential deviations or sites in need of retraining, ultimately helping sponsors generate the best-possible data.
Solution benefits:
- Good for routine trials and standard workflows
- Captures FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and other metrics
- Convenient carrying case for home-nurse visits, when necessary
- Multiprotocol support
- Better data resolution and more accurate overread
- Centralization can reduce variability by up to 50%
MasterScope™
Comprehensive solution for complex studies
The Clario MasterScope Clinical Trial Workstation combines a convenient wireless spirometry sensor with an intuitive multi-language software interface designed for complex workflows and diverse respiratory endpoints. The system is integrated with peripheral devices for seamless capture of ECG, FeNO inflammation or oscillometry endpoints and is designed to handle multiple protocols with ease.
Similar to the SpiroSphere, the MasterScope’s wireless handheld sensor is easy to clean and utilizes single-use, pre-calibrated pneumotach tubes for patient safety and hygiene. The MasterScope also leverages the Clario EXPERT® data platform as well as the same stringent review of data consistency and plausibility.
Solution benefits:
- Optimized data collection and workflows for complex protocols
- Captures FEV1, FVC, PEF, FEF25-75, VC, IC, ERV and other parameters
- Optional ECG, FeNO and oscillometry capture available
- Multi-language option for user interface
- Better data resolution and more accurate overread
- Centralization can reduce variability by up to 50%
Clario MasterScope Clinical Trial Workstation
Lower-cost site-based spirometry alternatives
SpiroSphere® Device
Stand-alone spirometer
Clario supported devices are designed for clinical trial protocols and have been vetted through hundreds of studies. Sponsors can utilize the Clario SpiroSphere® spirometer as a stand-alone device without centralized services.
Solution benefits:
- Only rent devices as needed
- Advanced and proven devices
- Spirometry curves can be printed locally or reported in a PDF format
Clario Link
Paper-based solution
Sponsors interested in utilizing existing site equipment can leverage the Clario Link, flexible paper-based solution. A combination of existing site equipment and Clario-provided rental equipment can also be utilized as needed. Paper readouts across all sites are converted to digital images and uploaded to the Clario EXPERT® portal for centralized overread and data reconciliation.
Solution benefits:
- Economic solution
- Only rent stand-alone devices as needed
- Gas supplied for any Clario-provided devices
- Compatible with most existing spirometry, DLCO or body plethysmography devices
- Same great training, overread, analysis and reporting
Related solutions
Virtual Home Spirometry
Remote spirometry testing for respiratory clinical trials.
Diffusing Capacity (DLCO)
Assessing the capacity of the lungs for effective gas transfer.
Cough and Lung Sounds
Assessment of cough frequency, cough severity and other lung sounds such as crackles or rhonchi for clinical trials.
Talk to a specialist
Our team of experts is available to address questions you may have about our integrated respiratory solutions. Submit your contact information and we’ll be in touch shortly.