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Machine Perfusion System
Machine Perfusion for Liver Transplant (PILOT™_CA Trial)
N/A
Recruiting
Research Sponsored by Organ Recovery Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will provide safety data to help evaluate a new medical treatment.
Who is the study for?
This trial is for adults over 18 who need a new liver and are on the UNOS waiting list. They must be first-time transplant recipients, not have HIV, severe infections, or acute liver failure. Pregnant individuals or those getting multiple organ transplants can't participate.
What is being tested?
The study tests the LifePort Liver Transporter System's performance in preserving livers for transplant through Hypothermic Machine Perfusion—a way to keep organs cold while supplying them with nutrients and oxygen before surgery.
What are the potential side effects?
Since this trial focuses on a machine perfusion system rather than a drug, traditional side effects aren't applicable. However, there may be risks related to how well the preserved liver functions after transplantation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Transplantation, Homologous
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hypothermic Machine PerfusionExperimental Treatment1 Intervention
Hypothermic Machine Perfusion with Organ Recovery Systems LifePort Liver Transporter system
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Who is running the clinical trial?
Organ Recovery Systems, Inc.Lead Sponsor
1 Previous Clinical Trials
142 Total Patients Enrolled
Stan HarrisStudy DirectorOrgan Recovery Systems
1 Previous Clinical Trials
142 Total Patients Enrolled
Matthew CopithorneStudy ChairOrgan Recovery Systems
1 Previous Clinical Trials
142 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood type does not match the donor liver's blood type.I am experiencing sudden severe liver failure.I am on the UNOS waiting list for a liver transplant.I have received a liver transplant for the first time.I have received multiple organ transplants.I am currently suffering from a severe infection.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Hypothermic Machine Perfusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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