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

NCT06711939 | Not Yet Recruiting

• 1 other identifier: 311α/ΔΣ-04/03/2024
• Study Type: observational
• Target: 515
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Provide a solution for easy-to-use breath analysis able to monitor the health of any individual at any setting.
2. 2.Develop and demonstrate the beyond state-of-the-art technologies needed to implement the VOCORDER breath analysis apparatus.
3. 3.Develop a health monitoring apparatus people can easily integrate into their everyday life.
4. 4.Demonstration of QCLs and ICLs monolithically integrated arrays.
5. 5.Integrate QCLs/ICLs arrays with MPLC components for beam combing and providing high quality beam profile.
6. 6.Implement a detector-less sensing scheme.
7. 7.Enable AI-based breath analysis for the identification of health conditions.
8. 8.Implement clinical studies of VOCORDER.

Conditions

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

Keywords

VOC; breath analysis; organ insufficiency; infections; Lung cancer; Gastric and colon cancer; Breast cancer; Kidney insufficiency; Infections - Pneumonia

Outcome Measures

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.

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

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mitera Hospital: lead
• 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

Study Sites (1)

Mitera Hospital

Athens, Attica, 15123, Greece

Location

Related Links

• The clinical study is part of Vocorder project presented at the above website

MeSH Terms

Conditions

Breast Neoplasms; Stomach Neoplasms; Colonic Neoplasms; Lung Neoplasms; Renal Insufficiency; Pneumonia; Infections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiratory Tract Infections

Central Study Contacts

FLORA KONTOPIDOU, MD,PhD

CONTACT

+30 6973989859; fkontopidou@mitera.gr

ZOE ZACHAROULI, Msc

CONTACT

+306944370325; fkontopidou@mitera.gr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infection control and Infectious disease specialist (MD,PhD)

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: December 2, 2024
• Study Start: December 9, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)