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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMitera Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients>18 years of age of both genders

They must be able to communicate and understand the information given to them by the MITERA staff.

Suffer from the disease under investigation.

The disease must be at the earliest possible stage, i.e., the patients must not yet have started treatment.

Disqualifiers

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

Trial population

The study will be conducted at MITERA Hospital. MITERA General Clinic, Maternity / Gynecological Clinic \& Children's Hospital has established itself as a leading healthcare facility, serving as a comprehensive care center for individuals of all ages. With 45 years of operation, MITERA stands out as one of Greece's most esteemed private hospitals, offering a wide range of high-quality health services aimed at the prevention, diagnosis and treatment across various medical fields. MITERA is home to three clinics: the General Clinic, the MITERA Maternity / Gynecological Clinic and the most comprehensive private pediatric clinic in Greece, the MITERA Children's Hospital. Hospitalised patients and out-patients of MITERA will be the patient population of the study. MITERA staff and other volunteers will be the healthy control population.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

515 Participants
are grouped into 2 trial groups
Group A: Control (Healthy)
Group B: Patients

Trial outcomes

Primary outcomes

1

Vocorder valistion in clinical practice

To validate the effectiveness of the VOCORDER device in clinical practice and to promote further the technology of breath analyses.

Time frame
At least 1 breath sample will be collected at 1 time point from each paricipant

Secondary outcomes

1

Operational parameters of Vocorder

Identify and define the operational parameters of the new technology of breath analyses in clinical practice.

Time frame
At least 1 breath sample will be collected at 1 time point from each paricipant
2

VOCORDER technology vs reference method

Compare the performance and outcomes of VOCORDER technology against the GC-MS reference method.

Time frame
At least 1 breath sample will be collected at 1 time point from each paricipant
3

VOC biomarkers linked to diseases under study

Investigate the correlation between known pre-existing conditions and significant VOC biomarkers in exhaled breath for selected diseases.

Time frame
At least 1 breath sample will be collected at 1 time point from each paricipant
4

VOC biomarkers for the early detection of diseases

Explore the potential of VOC biomarkers in exhaled breath for the early detection of diseases, facilitating timely diagnosis through correlation with key medical parameters.

Time frame
At least 1 breath sample will be collected at 1 time point from each paricipant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mitera Hospital

Lead sponsor

ETH Zurich (Switzerland)

Collaborator

Institute of Communications and Computer Systems, Athens, Greece

Collaborator

AIDEAS OU

Collaborator

ARGOS MESSTECHNIK GMBH

Collaborator

CAILABS

Collaborator

EULAMBIA ADVANCED TECHNOLOGIES ETAIRIA PERIORISMENIS EFTHINIS

Collaborator

Vrije Universiteit Brussel

Collaborator

NEURALTECH IKE

Collaborator

UAB METIS BALTIC

Collaborator

EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT

Collaborator

ALPES LASERS SA

Collaborator

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