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Clinical Trials/NCT04582279
NCT04582279
Recruiting
Not Applicable

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

Mayo Clinic1 site in 1 country90 target enrollmentOctober 28, 2020

Overview

Phase
Not Applicable
Intervention
Lung ultrasound
Conditions
Post-Lung Transplantation Bronchiectasis
Sponsor
Mayo Clinic
Enrollment
90
Locations
1
Primary Endpoint
Establish predictive value of lung ultrasound
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 28, 2020
End Date
December 30, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tathagat Narula

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Arms & Interventions

Receiving Ultrasound

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

Intervention: Lung ultrasound

Outcomes

Primary Outcomes

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

Study Sites (1)

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