Assessing the Pneumoscope Device for Respiratory Health Monitoring
Pivotal Study of the Performance and Safety of the Pneumoscope Device in Adults and Children
This study is testing a new device called the Pneumoscope to see if it can help doctors better monitor and diagnose respiratory issues in both healthy people and those with breathing problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Pediatric Clinical Research Platform Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT06373939 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance and safety of the Pneumoscope, a digital device that combines a stethoscope, pulse oximeter, and thermometer, in adults and children with respiratory diseases. The Pneumoscope aims to improve the accuracy of diagnosing conditions such as pneumonia and asthma by providing non-invasive measurements of respiratory sounds, oxygen saturation, and body temperature. Participants will include both healthy individuals and those with lower respiratory tract diseases or low oxygen levels. The study will be conducted at the Geneva University Hospitals, focusing on the effectiveness of this innovative tool in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include individuals over 1 year old, both healthy and those with respiratory conditions or low oxygen saturation.
Not a fit: Patients with severe clinical signs such as acute hypoxia or those with specific contraindications to the device may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enhance the accuracy of respiratory disease diagnosis and management, leading to better patient outcomes.
How similar studies have performed: While the Pneumoscope represents a novel approach, similar studies utilizing digital health tools for respiratory assessment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients will be recruited from the pediatric and adult clinical departments of the Geneva University Hospitals. Inclusion Criteria: * Age \> 1 year old. * Healthy patients on the day of auscultation OR * Patients with lower respiratory tract diseases (e.g., bronchitis, pneumonia, etc.). OR * Patients with low (i.e., \<92%) pulse oximetry values (e.g., cyanotic heart defect such as tetralogy of Fallot, transposition of great vessels, etc.). AND / OR * Patients with fever \>38.0°C. * And for all: Information and written consent of the patient or a legal representative. Exclusion Criteria: * Refusal of consent. * Clinical signs of severity: acute hypoxia, hypercapnia, acute respiratory failure, acute circulatory failure. * Immune disorder, primary ciliary dyskinesia, antecedent of neonatal bronchopulmonary dysplasia. * Contraindications and limitations of the MD as described in the instructions for use. * Contraindications to the class of medical devices being studied, e.g. known hypersensitivity or allergy to the device material. * Clinically significant concomitant disease states. * Inability to follow the study procedures, e.g. due to language problems, psychological disorders, dementia, etc. * Participation in another study with an investigational drug or other medical device within 30 days prior to and during the present study.
Where this trial is running
Geneva
- Geneva University Hospitals — Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Johan N Siebert, MD
- Email: Johan.Siebert@hcuge.ch
- Phone: (0)79 553 40 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.