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

NCT ID: NCT04582279

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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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

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Post-Lung Transplantation Bronchiectasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

There is only 1 group of participants being monitored. Every patient will follow the same study procedures
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

This study is not blinded

Study Groups

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Receiving Ultrasound

Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.

Group Type EXPERIMENTAL

Lung ultrasound

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Tathagat Narula

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tathagat Narula, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Neha Shukla

Role: primary

904-953-3966

Related Links

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Other Identifiers

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20-002489

Identifier Type: -

Identifier Source: org_study_id

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