Vocorder Device Validation in Clinical Settings - Continuous Monitoring of Individuals (Vocorder Clinical Validation-VCV). This Clinical Study Will Explore the Correlation Analysis Between Volatile Organic Compounds (VOC) Profiles in Breath As Detected by the VOCORDER Breath Analyser and Electronic Medical Data As Collected by Medical Professionals. the Obtained Results Are Expected to Be Significant in Refining the Technology of Breath Analysis in the VOCORDER Breath Analyser for the Early Detection of Diseases of Interest.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Vocorder valistion in clinical practice
研究概览
简要总结
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
- Provide a solution for easy-to-use breath analysis able to monitor the health of any individual at any setting.
- Develop and demonstrate the beyond state-of-the-art technologies needed to implement the VOCORDER breath analysis apparatus.
- Develop a health monitoring apparatus people can easily integrate into their everyday life.
Scientific and technological Objectives
- Demonstration of QCLs and ICLs monolithically integrated arrays.
- Integrate QCLs/ICLs arrays with MPLC components for beam combing and providing high quality beam profile.
- Implement a detector-less sensing scheme.
- Enable AI-based breath analysis for the identification of health conditions.
- Implement clinical studies of VOCORDER.
详细描述
Study design The hypothesis In the study of breathomics, several VOCs, VOC patterns and relationships among changes in VOC patterns are found to be related to different types of diseases. Therefore, changes in VOC patterns of the exhaled air correlate with particular conditions, as measured by specific disease-related VOC profiles.
Background and Objectives of the study This clinical study is being conducted as part of the HORIZON-EIC-2022 PATHFINDER CHALLENGES-01-04 project entitled Vocorder, a new technology for breath analyses. Breath sample collection for VOC analysis (patients and control group), VOCs may already be present at a base level. However, the VOCORDER instrument will be capable of resolving those concentration differences caused by changes in the metabolism and discriminate against those which may already be present in the environmental air. Thus, the analyser will allow an in-situ time-resolved measurement of different gases (e.g., VOCs), recording their concentration profile within single breaths with minimal supervision and almost no strict methodology. However, in this validation phase strict methodology will be applied to ensure the validity of the approach and the unobtrusiveness of the method.
The breath analyses will be performed using laser-based breath analyser prototypes capable to detect small number of gases simultaneously. QCL mid-IR Array-based self-mixing analyser for the detection of VOCs with measurement range in the 10-100 ppb, limit of detection close to 1 ppb, resolution close to 1 ppb and accuracy near ± 1 ppb. Identification of compounds will rely on a NIST mass spectral library and the comparison of their retention indices with the library of indices obtained for reference standards. The initial breath analyser will be able to be tested in healthy and incubated patients alike, since the sampling tube can be connected to the ventilator directly, in addition to its original use.
This clinical study will address the correlation analysis between breath VOCs profiles as detected by the VOCORDER breath analyser and Electronic medical data collected by medical professionals. The obtained results are expected to be essential for tailoring the technology of breath analysis in the VOCORDER breath analyser towards the early detection of diseases of interest.
The main objectives of this clinical study are as follows:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-75 years of both genders, selected according to the following inclusion criteria:
- •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.
- •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.
排除标准
- •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.
结局指标
主要结局
Vocorder valistion in clinical practice
时间窗: At 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.
次要结局
- Operational parameters of Vocorder(At least 1 breath sample will be collected at 1 time point from each paricipant)
- VOCORDER technology vs reference method(At least 1 breath sample will be collected at 1 time point from each paricipant)
- VOC biomarkers linked to diseases under study(At least 1 breath sample will be collected at 1 time point from each paricipant)
- VOC biomarkers for the early detection of diseases(At least 1 breath sample will be collected at 1 time point from each paricipant)
研究者
Dr Flora Kontopidou
Infection control and Infectious disease specialist (MD,PhD)
Mitera Hospital