Liver Transplantation
Conditions
Brief summary
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
Interventions
Storage and transportation of the donated liver using the OrganOx metra device.
Sponsors
North American Science Associates Ltd.
OrganOx Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 18 years of age or greater * Subject is registered as an active recipient on the UNOS waiting list for liver transplantation * Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization * Subject is able and willing to comply with all study requirements
Exclusion criteria
* Subject requiring all of the following at the time of transplantation: 1. Oxygen therapy via a ventilator/respirator 2. Inotropic support 3. Renal replacement therapy * Subject has acute/fulminant liver failure (UNOS status 1A) * Subject undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney) * Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing * Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Early Allograft Dysfunction (EAD) | 7 days | Severity of immediate graft injury as measured by early allograft dysfunction (EAD). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normothermic Machine Perfusion (NMP) Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions for Use.
Normothermic Machine Perfusion (NMP): Storage and transportation of the donated liver using the OrganOx metra device. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Normothermic Machine Perfusion (NMP) |
|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 13.2 |
| BMI | 31.8 Kg/m^2 STANDARD_DEVIATION 20.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 19 / 19 |
Outcome results
Primary
Incidence of Early Allograft Dysfunction (EAD)
Severity of immediate graft injury as measured by early allograft dysfunction (EAD).
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normothermic Machine Perfusion (NMP) | Incidence of Early Allograft Dysfunction (EAD) | 9 Participants |