Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

Condition(s) studied

Investigational drug(s) / intervention(s)

LungGuard: The LUNGguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for the LUNGguard is up to 8 hours.

BAROGuard: The BAROguard (the "System") is ultraportable hypothermic preservation and transport system intended for use with donor lungs. BAROguard is a legally marketed, FDA cleared medical device in the United States. The intended organ storage time for BAROguard™ is up to 8 hours.

Study summary

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients

Eligibility

Primary outcome measure(s)

• Number of subjects with Primary Graft Dysfunction (PGD) — Post-transplant through 5 years post
  The number of subjects that develop PGD after transplant
• Number of subjects with rejection — Post-transplant through 5 years post
  Subjects that show signs to rejection after transplant
• Survival — Post-transplant through 5 years post
  patient survival post-transplant
• ICU Length of Stay — Transplant through 5 years post-transplant
  Days the subject spent the ICU post-transplant
• Hospital Length of Stay — Transplant through 5 years post-transplant
  Days the subject was in the hospital in total after transplant

Trial sites (15)

More Paragonix Technologies trials in the USA

Other trials for the same condition