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

April 17, 2024 updated by: Tathagat Narula, Mayo Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Receiving Ultrasound
Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.
Diagnostic test: Lung ultrasound
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 0 to month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Tathagat Narula, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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