NCT03639025

OCS™ Lung TOP Registry For Donor Lungs for Transplantation

The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 458 (actual)
• Sponsor: TransMedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an all-comers registry that will enroll: 1. Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and 2. Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and 3. All donor lungs that were perfused on OCS Lung System. Enrolled patients will fall into one of the following three possible analysis categories: 1. TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System. 2. TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System. 3. All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations. Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.

Conditions

• Lung Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-10
• Primary completion: 2025-11-30
• Completion: 2029-11-30
• First posted: 2018-08-20
• Last updated: 2025-08-27

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study