Background
The primary product of the company, IscAlert, is the world’s first CO2 sensor designed for real-time ischemia detection across all organ types. By enabling continuous monitoring, IscAlert provides an early warning system to help clinicians intervene before irreversible damage occurs. The technology is cost-effective and easy to implement, setting it apart from traditional ischemia detection methods.
Study Overview
Sensocure initiated a single-site feasibility study at Vestfold Hospital Trust in Norway to assess the performance of IscAlert and CriticAlert, the latter monitoring non-invasively continuous and in real-time systemic pCO2 through nasal mucosa. The study, involving a limited number of patients, is designed to generate early clinical insights into the use of real-time CO2 monitoring for hypoventilation detection in patients with respiratory dysfunctions.
Choosing Ledidi Core
Sensocure evaluated Ledidi Core as a platform for designing and managing the study. Sensocure had previously set up a paper-based eCRF, and after seeing a short demonstration of Ledidi Core, they were able to set up the entire study in Ledidi themselves.
The study was structured using 13 forms, incorporating 200 variables for healthy volunteers and 270 variables for patients. Sensocure’s Principal Scientist, Espen Lindholm, reported that setting up the entire study, including all dependencies, took only five workdays. This approach not only expedited the process but also reduced costs significantly compared to the traditional route of hiring a contract research organisation (CRO).
Espen Lindholm, Principal Scientist at Sensocure said “Ledidi Core has been instrumental in streamlining the setup and execution of our feasibility study. The platform’s intuitive, web-based interface allowed us to design an eCRF without requiring assistance from IT specialists, saving both time and resources. Its user-friendly design ensures that hospital staff can easily input data with minimal risk of errors, which is crucial for maintaining data integrity. For our needs, Ledidi Core has proven to be the ideal solution.”
Study Progress
As of February 2025, the first patient has been enrolled in the feasibility study. Sensocure anticipates that the study will provide valuable clinical data to support the continued development and adoption of IscAlert and CriticAlert.
For more information about Sensocure and their sensors, visit Sensocure’s website.