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Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA) (PILOT™_CA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05574361
Recruitment Status : Recruiting
First Posted : October 10, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Organ Recovery Systems, Inc.

Brief Summary:
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial

Condition or disease Intervention/treatment Phase
Liver Transplantation Device: Hypothermic Machine Perfusion Not Applicable

Detailed Description:
To provide continued access for the LLT System with Vasosol® for the preservation of whole explanted livers, thereby providing additional safety data in support of the PILOT pivotal efficacy and safety trial

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multi-Center Continued Access Protocol for the Use of the LifePort® Liver Transporter (LLT) System With Vasosol® in Orthotopic Liver Transplants (PILOT™_CA: Perfusion to Improve Liver Outcomes in Transplantation_ Continued Access Arm)
Actual Study Start Date : September 19, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypothermic Machine Perfusion
Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system
Device: Hypothermic Machine Perfusion
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution




Primary Outcome Measures :
  1. Early Allograft Dysfunction (EAD) [ Time Frame: 7 days ]
    EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) >2000IU/L or Alanine Aminotransferase (ALT) > 2000 IU/L



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • ≥18 years of age.
  • Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation.
  • De novo liver transplant recipient.
  • Written informed consent required.

Exclusion Criteria:

  • Subject is a multi-organ transplant recipient.
  • Subject is antibodies blood group (ABO) liver incompatible.
  • Subject has severe systemic infection.
  • Subject is Human Immunodeficiency Virus (HIV) positive.
  • Subject has acute/fulminant liver failure.
  • Subject is pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05574361


Contacts
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Contact: Stan Harris 847-824-2600 sharris@organ-recovery.com
Contact: Carrie Lindower 847-824-2600 clindower@organ-recovery.com

Locations
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United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Daniel Borja-Cacho, MD         
United States, New Jersey
Rutgers New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07101
Contact: James V. Guarrera, MD         
Sponsors and Collaborators
Organ Recovery Systems, Inc.
Investigators
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Study Director: Stan Harris Organ Recovery Systems
Study Chair: Matthew Copithorne Organ Recovery Systems
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Responsible Party: Organ Recovery Systems, Inc.
ClinicalTrials.gov Identifier: NCT05574361    
Other Study ID Numbers: 2020-US-02-ORS
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes