Post-Lung Transplantation BronchiectasisNCT04582279

Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients

A study testing Lung ultrasound in people with Post-Lung Transplantation Bronchiectasis, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Post-Lung Transplantation Bronchiectasis
What is being tested?: Lung ultrasound
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2020to 30 Dec 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

Mayo Clinic in Florida
Jacksonville, Florida, 32224
Neha Shukla, 904-953-3966, shukla.neha@mayo.edu
Recruiting

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About this study

Official title: Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients

This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.

Read the detailed description

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.

Conditions: Post-Lung Transplantation Bronchiectasis
Being tested: Lung ultrasound
Keywords: Post lung transplant, Lung bronchoscopy, Lung biopsy, Lung rejection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lung ultrasoundDiagnostic test
The 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.

Study groups in NCT04582279
Study group	Role	What they receive
Receiving Ultrasound	Experimental	Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops. Receives: Diagnostic Test: Lung ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

Establish predictive value of lung ultrasound
Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy
Measured: Month 0 to month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202030 Dec 2026

First posted9 Oct 2020
Study start28 Oct 2020
Primary completion30 Oct 2026 (estimated)
Study completion30 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Post-Lung Transplantation BronchiectasisStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: There is only 1 group of participants being monitored. Every patient will follow the same study procedures
Masking: None (open label)
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04582279
Sponsor's protocol ID: 20-002489
Status last verified: Feb 2026
First submitted: 7 Oct 2020
Last updated: 5 Feb 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
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