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

NCT04582279 | Recruiting FDA Device

• 1 other identifier: 20-002489
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-Lung Transplantation Bronchiectasis

Keywords

Post lung transplant; Lung bronchoscopy; Lung biopsy; Lung rejection

Outcome Measures

Primary Outcomes (1)

• Establish predictive value of lung ultrasound

  Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy

  Month 0 to month 12

Study Arms (1)

Receiving Ultrasound

EXPERIMENTAL

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

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasound 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.

Receiving Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Tathagat Narula, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study is not blinded
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There is only 1 group of participants being monitored. Every patient will follow the same study procedures

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 9, 2020
• Study Start: October 28, 2020
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)