NCT04186221

OCS Liver PROTECT Continued Access Protocol

Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: TransMedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

Detailed description

A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics: 1. Donor age equal to or greater than 40 years old, or 2. Expected cross clamp time of 6 hours or greater, or 3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or 4. Steatotic lever \>0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology) A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function. All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DEVICE	OCS Liver System	OCS Liver System for preserving and assessing donor livers for transplantation

Timeline

• Start date: 2020-02-03
• Primary completion: 2021-02-02
• Completion: 2023-02-02
• First posted: 2019-12-04
• Last updated: 2024-07-24
• Results posted: 2024-07-24

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study