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Device

Ex Vivo Lung Perfusion for End-Stage Lung Disease

N/A

Waitlist Available

Research Sponsored by Lung Bioengineering Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient undergoes lung transplantation

Aged 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test whether the CLES machine can safely and effectively evaluate donor lungs for transplantation in people with end-stage lung disease.

Who is the study for?

This trial is for adults over 18 with severe lung disease who need a lung transplant and can give informed consent. It's not for those needing multiple organ transplants, re-transplantation of the same side lung, live donor lobar transplants, or patients with HIV or Burkholderia cenocepacia infection.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of a Centralized Lung Evaluation System (CLES) to assess potential donor lungs that are usually not used for transplantation. The goal is to see if this system helps patients survive at least six months after receiving a new lung.See study design

What are the potential side effects?

Since this trial involves evaluating donor lungs and subsequent transplantation, potential side effects may include typical post-transplant complications such as rejection of the new organ, infections due to immunosuppression therapy, and surgical risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have had a lung transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

12 month survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EVLPExperimental Treatment2 Interventions

Group II: ControlActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Centralized Lung Evaluation System

2019

N/A

~180

Lung Transplant

2019

N/A

~180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lung Bioengineering Inc.Lead Sponsor

1 Previous Clinical Trials

118 Total Patients Enrolled

Media Library

Centralized Lung Evaluation System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03641677 — N/A

Lung Disease Research Study Groups: Control, EVLP

Lung Disease Clinical Trial 2023: Centralized Lung Evaluation System Highlights & Side Effects. Trial Name: NCT03641677 — N/A

Centralized Lung Evaluation System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03641677 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity to enrol participants in this clinical trial?

"Affirmative, the clinicaltrials.gov database reflects that this research trial is presently recruiting participants. Initially posted on January 15th 2019 and most recently updated on May 13th 2022, it plans to recruit 186 individuals from 11 medical centres."

Answered by AI

How many participants are contributing to the data gathered from this research?

"Yes, clinicaltrials.gov has information affirming that this trial is currently in search of individuals to participate. This medical study went live on January 15th 2019 and was most recently updated on May 13th 2022; 186 subjects are needed from 11 different hospitals."

Answered by AI

In how many locations is this experiment currently being conducted?

"This research project is presently enrolling patients in 11 different clinics, including those located within Grand Rapids, Ann Arbor and Cleveland. To minimize travel stressors, it is important to select the closest clinic for enrollment if you choose to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

2019. "Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03641677.