Trials / Terminated
TerminatedNCT03343535
OCS Lung System EXPAND II Trial
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCS Lung Preservation | OCS Lung Preservation |
Timeline
- Start date
- 2018-03-12
- Primary completion
- 2019-08-27
- Completion
- 2022-07-06
- First posted
- 2017-11-17
- Last updated
- 2024-02-28
- Results posted
- 2024-02-28
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03343535. Inclusion in this directory is not an endorsement.