Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 11:19 PM
Study NCT ID:
NCT03343535
Status:
TERMINATED
Last Update Posted:
2024-02-28
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OCS Lung System EXPAND II Trial
Sponsor:
TransMedics
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment in EXPAND II was stopped June 24, 2019 as a result of the FDA approval for the EXPAND indication. Therefore, no additional sites or subjects were enrolled after that time.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: