Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

Enrolling by invitationOBSERVATIONAL
Enrollment

2,000

Participants

Timeline

Start Date

October 15, 2021

Primary Completion Date

June 15, 2028

Study Completion Date

December 30, 2029

Conditions
Interstitial Lung DiseaseCOPDCystic FibrosisPulmonary FibrosisPulmonary Arterial HypertensionEmphysema
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."

Trial Locations (15)

3000

University Hospitals Leuven, Leuven

10467

Montefiore Hospital, The Bronx

15213

University of Pittsburgh Medical Center, Pittsburgh

19140

Temple University Hospital, Philadelphia

21218

Johns Hopkins University, Baltimore

22908

University of Virginia, Charlottesville

27710

Duke Lung Transplant Clinic, Durham

32224

Mayo Clinic Jacksonville, Jacksonville

75246

Baylor Scott & White Research Institute, Dallas

75390

The University of Texas Southwestern Medical Center, Dallas

77030

Houston Methodist Hospital, Houston

85013

St. Joseph's Hospital and Medical Center, Phoenix

94143

University of California, San Francisco, San Francisco

94305

Stanford Medicine, Stanford

02114

Massachusetts General Hospital, Boston

Sponsors
All Listed Sponsors
lead

Paragonix Technologies

INDUSTRY

NCT04930289 - Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs | Biotech Hunter | Biotech Hunter