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Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

NCT04930289 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-05-15

No results posted yet for this 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

Conditions

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Paragonix Technologies

    lead INDUSTRY

Principal Investigators

  • Matthew Hartwig, MD · Duke University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2028-06-15
Completion
2029-12-30
FDA Device
Yes

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04930289 on ClinicalTrials.gov