Open Actively Recruiting

OCS™ Lung TOP Registry For Donor Lungs for Transplantation

About

Brief Summary

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

Study Type
observational_patient_registry
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

This is an all-comers registry that will enroll all:

  • Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
  • Consented patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
  • All donor lungs that were perfused on OCS Lung System. Enrolled patients will fall into one of the following three possible analysis categories:
  • TOP SCDL PAS Primary Analysis Population: will be comprised of the first 289 eligible/PAS consented recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  • TOP DLIDU Primary Analysis Population: Will be comprised of the first 266 eligible/PAS consented recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  • 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.

Join this Trial

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Study Stats
Protocol No.
18-002071
Category
Surgery
Contact
NANCY SATOU
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03639025
For detailed technical eligibility, visit ClinicalTrials.gov.