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

Launched by MITERA HOSPITAL · Nov 27, 2024

Keywords

ClinConnect Summary

The Vocorder Clinical Validation trial is studying a new portable device that can continuously monitor health by analyzing a person’s breath. The goal is to create a simple, non-invasive tool that helps detect early signs of health issues, especially in patients with various types of cancer, kidney problems, and pneumonia. By monitoring breath, the device aims to provide valuable information to both individuals and healthcare providers, making it easier to manage health proactively.

To be eligible for this trial, participants must be between 18 and 75 years old and have one of the diseases being studied, but they should not have started treatment yet. They should also be able to understand the information given to them by the study staff. Healthy individuals aged 20 to 75 may also participate as a comparison group. Participants can expect to provide breath samples to help researchers learn more about how this device works. It's important to note that anyone who cannot follow the study guidelines or provide a reliable breath sample will not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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.
• Exclusion Criteria:
• • 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.