Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Location status: Recruiting
Recruiting
NCT Number: NCT04582279
Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients
This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Lung transplant recipients are at high risk for lung rejection and lung infection after transplant. This is diagnosed by performing lung bronchoscopies and lung biopsies. These procedures carry an increased risk for complications and are costly. This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult patients (> 18 yrs) who had undergone single/double/heart-lung transplant
- Asymptomatic
- Normal spirometry defined as a FEV1 without significant drop from baseline (significant drop = >10% decrease from baseline)
- Clear chest radiograph over allograft
Exclusion criteria
- Patients who are unable to consent for the procedure
- Patients with subcutaneous emphysema or other technical challenges that could interfere with satisfactory image acquisition- as deemed by the operator.
Treatment and study plan
Lung Ultrasound
Diagnostic TestThe lung ultrasound will be performed by a trained pulmonologist by gently pressing a probe to various areas of your chest. This is a non-invasive procedure and you should not feel any pain. The ultrasound will take less than 10 minutes.
Primary outcomes
-
Establish predictive value of lung ultrasound
Time frame: Month 0 to month 12
Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy
Sponsors and collaborators
Lead sponsor
Mayo Clinic
Other
Registry information
Official study title
Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients
Important dates
- Study start
- 2020
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Oct 9, 2020
- Registry last updated
- Feb 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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