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OCS Lung System EXPAND II Trial

Sponsor
TransMedics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03343535
Collaborator
(none)
46
Enrollment
14
Locations
1
Arm
51.6
Anticipated Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Condition or Disease Intervention/Treatment Phase
  • Device: OCS Lung Preservation
 N/A

Detailed Description

Inclusion

At least one of the following:

  • Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or

  • Expected cross-clamp time > 6 hours for the second lung; or

  • Donor after Cardiac Death (DCD donor); or

  • Donor age ≥ 55 years old

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
OCS Lung SystemOCS Lung System
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation
Actual Study Start Date :
Mar 12, 2018
Actual Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: OCS

OCS Lung Preservation

Device: OCS Lung Preservation
OCS Lung Preservation
Other Names:
  • OCS Lung Transplant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient Survival [30 days post transplantation]

      Patient survival at Day-30 post-transplantation and at initial hospital discharge post-transplantation, whichever occurs later.

    2. Donor Lung Utilization Rate [Immediately at Transplantation]

      Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.

    Secondary Outcome Measures

    1. Primary Graft Dysfunction Grade 3 [within 72 hours pos-transplant]

      Incidence of Primary Graft Dysfunction Grade 3 on post-operative day 3

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female primary double lung transplant candidate

    • Age ≥ 18 years old

    • Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

    Exclusion Criteria:

    • Prior solid organ or bone marrow transplant

    • Single lung recipient

    • Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis

    • Participant in any other clinical or investigational trials/programs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Joseph's Hospital and Medical Center Phoenix Arizona United States 85013
    2 UCLA Medical Center Los Angeles California United States 90095
    3 University of California, San Francisco San Francisco California United States 94143
    4 Stanford University Medical Center Stanford California United States 94305
    5 The Johns Hopkins Hospital Baltimore Maryland United States 21287
    6 Massachusetts General Hospital Boston Massachusetts United States 02114
    7 University of Minnesota Minneapolis Minnesota United States 55455
    8 University of Nebraska Omaha Nebraska United States 68198
    9 Duke University Medical Center Durham North Carolina United States 27710
    10 Temple University Hospital Philadelphia Pennsylvania United States 19140
    11 Baylor St. Luke's Medical Center Houston Texas United States 77030
    12 Houston Methodist Houston Texas United States 77030
    13 University of Virginia Charlottesville Virginia United States 22908
    14 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • TransMedics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TransMedics
    ClinicalTrials.gov Identifier:
    NCT03343535
    Other Study ID Numbers:
    • OCS-LUN-012017
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by TransMedics
    portable ex-vivo lung perfusion
    breathing lung transplant
    portable OCS Lung System

    Study Results

    No Results Posted as of Nov 19, 2020