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OCS™ Lung TOP Registry For Donor Lungs for Transplantation

NCT03639025 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 458

Last updated 2025-08-27

No results posted yet for this study

Summary

Single-arm, prospective, multi-center, post-approval U.S. registry

Conditions

  • Lung Transplantation

Interventions

DEVICE

OCS Lung System

The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions: * Reducing ischemic injury through the use of warm, oxygenated blood based perfusion. * Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients. * Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.

Sponsors & Collaborators

  • TransMedics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2025-11-30
Completion
2029-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639025 on ClinicalTrials.gov