Vocorder Device Validation in Clinical Settings - Continuous Monitoring of Individuals (Vocorder Clinical Validation-VCV)

This is performed under Vocorder project that is Co-Funded by the European Union. (Grant Agreement 101115442 VOCORDER HORIZON EIC-2022-PATHFINDERCHALLENGE-01). The projects has 9 work packages (one dedicated to the clinical study) and 12 partners (collaborators). MITERA Hospital serves as the project Coordinator as well as the leader of the clinical study. VOCORDER aims to create a paradigm shift in healthcare monitoring by developing a portable device for continuous assessment of health through breath analysis. Our mission is to make health monitoring seamless and non-intrusive, empowering individuals and healthcare professionals with real-time data and proactive health management. Our vision is to make continuous health monitoring a part of everyday life, helping in early disease detection and management. We are on a mission to create accessible, easy-to-use technology that integrates seamlessly into daily routines. Our objective is to create a tool designed for the discreet and continuous monitoring of human health. This involves the development and implementation of a system that can consistently assess, process, and analyze human breath. The key aim is to detect early indicators of diseases, thereby facilitating timely and proactive healthcare interventions. Strategic objectives 1. Provide a solution for easy-to-use breath analysis able to monitor the health of any individual at any setting. 2. Develop and demonstrate the beyond state-of-the-art technologies needed to implement the VOCORDER breath analysis apparatus. 3. Develop a health monitoring apparatus people can easily integrate into their everyday life. Scientific and technological Objectives 1. Demonstration of QCLs and ICLs monolithically integrated arrays. 2. Integrate QCLs/ICLs arrays with MPLC components for beam combing and providing high quality beam profile. 3. Implement a detector-less sensing scheme. 4. Enable AI-based breath analysis for the identification of health conditions. 5. Implement clinical studies of VOCORDER.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

* Patients aged 18-75 years of both genders, selected according to the following inclusion criteria:

  1. Patients\>18 years of age of both genders
  2. They must be able to communicate and understand the information given to them by the MITERA staff.
  3. Suffer from the disease under investigation.
  4. The disease must be at the earliest possible stage, i.e., the patients must not yet have started treatment.
  5. Patients should have no other serious comorbidities that affect the derived measurements. Patients will be selected in collaboration with the clinicians responsible for the treatment and/or hospitalisation of patients with the diseases under investigation.

     Criteria 1, 2, and 3 are mandatory for enrollment in the study. For the enrollment of the patients in the study specific documentation of the disease should be available to the project team as following:
* Healthy controls of both sexes, aged between 20 and 75 years, who do not suffer from the diseases under investigation will be selected for participation in the study at the same time as the patients.

Exclusion Criteria:

* Lack of signed consent
* Lack of co-operation due to any reason
* Failure to follow the recommendations on the requirements prior to the breath sampling procedure
* Inability to provide a reliable breath sample
* Any treatment, specific diet, surgery, or other intervention having been initiated between obtaining samples for breath VOCs.

• DERIVEDKontopidou F, Swift SJ, Kokkotis C, Moustakidis S, Kavouras I, Vidaki AN, Brebou S, Zavvos V, Panagiotou A, Iatrou C, Grosomanidis D, Zacharouli Z, Giannoukos S. Evaluating the VOCORDER device for early disease detection through breath analysis: study protocol for a two-phase clinical study. BMJ Open. 2026 Jun 3;16(6):e108562. doi: 10.1136/bmjopen-2025-108562. PMID 42236089