Back to resultsLung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients
Primary Purpose
Post-Lung Transplantation Bronchiectasis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lung ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Post-Lung Transplantation Bronchiectasis focused on measuring Post lung transplant, Lung bronchoscopy, Lung biopsy, Lung rejection
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.
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Receiving Ultrasound
Arm Description
Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.
Outcomes
Primary Outcome Measures
Establish predictive value of lung ultrasound
Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04582279
Brief Title
Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients
Official Title
Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Lung Transplantation Bronchiectasis
Keywords
Post lung transplant, Lung bronchoscopy, Lung biopsy, Lung rejection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
There is only 1 group of participants being monitored. Every patient will follow the same study procedures
Masking
None (Open Label)
Masking Description
This study is not blinded
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Receiving Ultrasound
Arm Type
Experimental
Arm Description
Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Establish predictive value of lung ultrasound
Description
Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy
Time Frame
Month 0 to month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tathagat Narula, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katelyn Register
Phone
904-953-8503
Email
register.katelyn@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients
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