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.
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
- Are there results?
- Not yet: the study is under way
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
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Neha Shukla, 904-953-3966, shukla.neha@mayo.edu
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tathagat Narula, Mayo Clinic
- Investigators
- Tathagat Narula, MD, Principal investigator, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT04582279
- Acronym / sponsor ID
- 20-002489
- Conditions
- Post-Lung Transplantation Bronchiectasis
- Keywords
- Post lung transplant, Lung bronchoscopy, Lung biopsy, Lung rejection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is only 1 group of participants being monitored. Every patient will follow the same study procedures
| Arm | Type | Receives |
|---|---|---|
| Receiving Ultrasound | Experimental | Diagnostic Test: Lung ultrasoundEvery patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundThe 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. | Diagnostic test | Receiving Ultrasound |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Post-Lung Transplantation Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tathagat Narula, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasound in people with Post-Lung Transplantation Bronchiectasis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish predictive value of lung ultrasound (time frame: Month 0 to month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.