Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath

NCT06135220 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2025-01-13

No results posted yet for this study

Summary

In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested.

In pre-clinical studies, the investigators have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath, and several of these were also found in a first in-human clinical study what the investigators performed in 2019-2020 (DOI 10.1088/1752-7163/ad0aaa). These biomarkers need consolidation in a clinical setting using an updated collection device and proteomic analysis platform before development of a prototype and further test of this new diagnostic method.

Conditions

Interventions

DIAGNOSTIC_TEST

New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath.

The collection time will be an average of 7 minutes. As the patient breathes through a mouthpiece, the exhaled breath is lead through the collection device, and an indicative amount af the exhaled air is led into a clear plastic bag. When the plastic bag is fully inflated, it indicates that the minimum required amount of exhaled breath (approximately 30 liters) has passed through the filter.

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER
  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Inger L Gade, MD., Ph.D. · Aalborg University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06135220 on ClinicalTrials.gov