Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Paragonix Technologies
Study ID
NCT04930289
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • LungGuard — DEVICE
    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 — DEVICE
    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 Details

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

Key Dates

Start date
Oct 15, 2021
Status verified
May 2025
Primary completion
Jun 15, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: LungGuard patients
    Patients whose donor lung(s) was transported with the LungGuard device.
  • Arm: Standard Transport Patients
    Patients whose donor lung(s) was transported with a method other than the LungGuard
  • Arm: BAROGuard Patients
    Patients whose donor lung(s) was transported with the BAROGuard device.

Primary Outcome Measure

Number of subjects with Primary Graft Dysfunction (PGD) [ Time Frame: Post-transplant through 1 year post ]

Locations (14)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013-
University of California, San FranciscoSan FranciscoCalifornia94143-
Stanford MedicineStanfordCalifornia94305-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Johns Hopkins UniversityBaltimoreMaryland21218-
Massachusetts General HospitalBostonMassachusetts02114-
Montefiore HospitalThe BronxNew York10467-
Duke Lung Transplant ClinicDurhamNorth Carolina27710-
Temple University HospitalPhiladelphiaPennsylvania19140-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Baylor Scott & White Research InstituteDallasTexas75246-
The University of Texas Southwestern Medical CenterDallasTexas75390-
Houston Methodist HospitalHoustonTexas77030-
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Phoenix, AZ

By condition
COPD
By specialty
PulmonologyLung disease
By research site
St. Joseph's Hospital and Medical Center· Phoenix, AZUniversity of California, San Francisco· San Francisco, CAStanford Medicine· Stanford, CAMayo Clinic Jacksonville· Jacksonville, FLJohns Hopkins University· Baltimore, MDMassachusetts General Hospital· Boston, MA

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