Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06711939

Non recluta ancora

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

Osservazionale

Fase non elencata

Mitera Hospital

Sponsor: Mitera Hospital

Ultimo Aggiornamento: 2 dicembre 2024
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Mutazioni richieste

Nessuno

Studio Iniziato

9 dicembre 2024

Ultimo Aggiornamento dello Sponsor

2 dicembre 2024

Completamento Stimato

31 agosto 2025

Contatto dello studio

Nome:FLORA KONTOPIDOU, MD,PhD

Email:fkontopidou@mitera.gr

Telefono:+30 6973989859

Nome:ZOE ZACHAROULI, Msc

Email:fkontopidou@mitera.gr

Telefono:+306944370325

Idoneità

Criteri di Inclusione

* 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.

Criteri di Esclusione

* 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.

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Dettagli del Disegno

AllocazioneN/A

Modello di InterventoN/A

MascheramentoN/A

Numero da Arruolare515

Bracci e Interventi

Bracci

Interventi

Tipo: N/A

Descrizione: At least 240 healthy controls for both phases of the study, 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. The same healthy controls will participate in both phases of the study, and the breath samples obtained will be analyzed using both methods. The prospective controls will fill in a questionnaire with demographic and medical-history data after having been informed in detail about the study by the VOCORDER team of MITERA. The questionnaire will be analyzed by the project team, and if it is concluded that the person can participate in the study, a consent form will be signed by the participant.

Interventi:

Misure di Esito

Misure di Esito Primarie

Vocorder valistion in clinical practiceAt least 1 breath sample will be collected at 1 time point from each paricipant

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

Misure di Esito Secondarie

Operational parameters of VocorderAt least 1 breath sample will be collected at 1 time point from each paricipant

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

VOCORDER technology vs reference methodAt least 1 breath sample will be collected at 1 time point from each paricipant

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

VOC biomarkers linked to diseases under studyAt least 1 breath sample will be collected at 1 time point from each paricipant

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

VOC biomarkers for the early detection of diseasesAt least 1 breath sample will be collected at 1 time point from each paricipant

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

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Siti dello Studio

Mitera Hospital

Athens, Attiki, GR

Nome:Zoe Zacharouli

Email:zzacharouli@mitera.gr

Telefono:+306944370325

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