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

Sponsor
Mitera Hospital
Study ID
NCT06711939
Status
Not Yet Recruiting

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Conditions

  • Cancer of Stomach
  • Cancer of the Breast
  • Colon Cancer
  • Kidney Insufficiency
  • Lung Cancers
  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Dec 2, 2024
Start date
Dec 9, 2024
Status verified
Mar 2024
Primary completion
Aug 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
515 participants (estimated)

Arms

  • Arm: Control (Healthy)
    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.
  • Arm: Patients
    A total of 275 patients, 55 for each disease, 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.

Primary Outcome Measure

Vocorder valistion in clinical practice [ Time Frame: At least 1 breath sample will be collected at 1 time point from each paricipant ]

Central Contacts

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