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VitaloJAK | Clinical Trial Solution
The VitaloJAK is a unique development from Vitalograph in partnership with internationally renowned cough researchers working at Manchester University NHS Foundation Trust, UK.
The VitaloJAK® Cough Monitor provides the only fully validated system for objective measurement of cough in clinical trials. Ambulatory cough recordings of up to 24 hours undergo centralized, semi-automated analysis to provide quantified data. The VitaloJAK algorithm removes non-cough data from cough recordings, reducing the file size to allow efficient analysis by our team of trained cough analysts. Data generated by the system is proven to have median sensitivity >99% and excellent integrity. The system has been used for research since 2005 and in Phase 2 and 3 studies globally since 2014. This is a validated, 510k cleared and CE marked medical device system.
Using analysis software and processes developed in partnership with internationally renowned cough researchers working at Manchester University NHS Foundation Trust, the VitaloJAK system comprises 4 distinct components, all essential to ensure high quality data:
VitaloJAK high fidelity cough monitoring device and test kits
Vitalograph Web Portal to collect and manage analysis of cough data
VitaloJAK algorithm to remove non-cough sounds
Cough Analysis by trained cough analysts including event markers for awake and sleep periods
eLearning modules for cough studies are available via Vitalograph Web Portal. VitaloJAK system QA processes have been independently validated and found to support exceptionally high data accuracy1. The VitaloJAK Cough Monitor has proven suitable for quantifying 24 hour cough sessions in large Phase 2 and 3 studies where other methods of cough data collection and analysis are too costly, time consuming or inconsistent. Alternative recording periods can be configured. Study endpoint is typically “average hourly cough count”. 1 “measures of both intra- and inter-rater reliability for both filtered and full-length 24-hour recordings were found to be excellent, exceeding a reliability of 0.99” Mines et al, 2019.
The VitaloJAK system is used to count cough instances using a combination of an algorithm and a cough analysis process developed in partnership with Prof. Smith at Manchester University NHS Foundation Trust (MFT), UK. Dual sensors overcome recording problems from muffling caused by PPE masks and cough suppression. The device is typically used in large Phase 2 and 3 studies where the cost of other methods of cough data collection and analysis would be too costly, time-consuming, or inconsistent. The system has also been used in smaller academic studies in partnership with Vitalograph.
VitaloJAK Cough Monitor | |
|---|---|
Model Number | 7100 |
Size | 78mm x 108mm x 32mm (device) |
Weight | 240g - device with battery pack |
QA/GMP Standards | EN ISO 13485, SOR/98-282 & FDA 21 CFR 820 |
Medical Device Classification | II (US)/IIa (EU) |
Memory | Internal Memory: 32 GB |
Communications | USB 2.0/3.0 |
User Interface | Colour LCD 4 button keypad for configuration and event marking On/off key switch |
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