OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection

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

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-31

Study Completion Date

2021-09-30

Brief Summary

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Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.

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Detailed Description

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The purpose of this continuation study is to collect five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. The EXPAND Lung trial results have been presented and have shown positive results in the use of expanded criteria donor lungs and patient follow-up, post-transplant. The current study is being conducted to continue to collect follow-up on participants in the EXPAND study, in order to evaluate long-term patient survival status and BOS diagnosis.

Conditions

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OCS Lung System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OCS Expand Trial Cohort

All patients previously enrolled in the EXPAND Lung trial.

OCS Lung System

Intervention Type DEVICE

Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.

Interventions

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OCS Lung System

Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Registered male or female primary double lung transplant candidate
* Age ≥18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information