Status:

RECRUITING

Performance and Safety of the Pneumoscope Device in Adults and Children

Lead Sponsor:

Pediatric Clinical Research Platform

Collaborating Sponsors:

University Hospital, Geneva

Conditions:

Respiratory Diseases

Pneumonia

Eligibility:

All Genders

1+ years

Phase:

NA

Brief Summary

Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management. Clinicians use three par...

Detailed Description

Respiratory diseases affect over 500 million people globally, ranking third in causes of death. Chronic obstructive pulmonary diseases impact 251 million individuals due to air pollution and tobacco s...

Eligibility 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.

Key Trial Info

Start Date :

April 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

225 Patients enrolled

Trial Details

Trial ID

NCT06373939

Start Date

April 15 2024

End Date

December 31 2024

Last Update

July 3 2024

Active Locations (1)

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1

Geneva University Hospitals

Geneva, Switzerland, 1205