Trials / Enrolling By Invitation
Enrolling By InvitationNCT04930289
Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
Global Utilization and Registry Database for Improved Preservation of Donor Lungs
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Paragonix Technologies · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Detailed description
GUARDIAN-Lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lungs was preserved and transported within the LUNGguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria. About 500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 5 clinical sites. Candidates that fit the eligibility criteria and have had their donor lungs transported with a Paragonix product or a standard of care method can be enrolled. The baseline characteristics and outcomes of the two groups will be compared.
Conditions
- Interstitial Lung Disease
- COPD
- Cystic Fibrosis
- Pulmonary Fibrosis
- Pulmonary Arterial Hypertension
- Emphysema
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-10-15
- Primary completion
- 2028-06-15
- Completion
- 2029-12-30
- First posted
- 2021-06-18
- Last updated
- 2025-05-15
Locations
15 sites across 2 countries: United States, Belgium
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04930289. Inclusion in this directory is not an endorsement.