US National TOP Registry

NCT ID: NCT06513091

Last Updated: 2025-09-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-23

Study Completion Date

2039-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OCS Lung Transplant Recipients

The US National TOP Registry will enroll all liver transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry.

OCS Lung

Intervention Type DEVICE

The TransMedics Organ Care System (OCS) Lung is an FDA approved portable extracorporeal lung perfusion and monitoring system.

Non-OCS Lung Transplant Recipients

Patients transplanted using other preservation modalities for benchmarking clinical outcomes.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OCS Lung

The TransMedics Organ Care System (OCS) Lung is an FDA approved portable extracorporeal lung perfusion and monitoring system.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

All lung transplant recipients
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TransMedics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Site Status RECRUITING

Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Baylor Scott & White Research Institute

Dallas, Texas, United States

Site Status RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julia Church

Role: CONTACT

9782893546

Kausar Qidwai

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Brian Mutoff

Role: primary

Tiffany Koyano

Role: primary

650-206-0141

Nicholas Lemke

Role: primary

Sarah Casalinova

Role: primary

Erin Lee

Role: primary

214-818-7621

Andres Leon Pena, MD

Role: primary

713-798-7533

Kelly Potzner

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OCS-LUN-TOP-II

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hepatic Transplantation Registry
NCT05944042 RECRUITING
A2 to O Lung Transplants
NCT05581745 RECRUITING NA