US National TOP Registry

Recruiting

• Conditions: Lung Transplant

• Registration Number: NCT06513091
• Lead Sponsor: TransMedics

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-22
• Study Start: 2025-01-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-03
• Primary Completion: 2034-11
• Study Completion: 2039-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One-year patient and graft survival	1-year post-transplant	Recipients' one-year patient and graft survival rates

Trial Locations

Locations (7)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

St. Joseph's Hospital & Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States