Extracorporeal Membrane Oxygenation (ECMO) provides respiratory and circulatory support in patients with severe cardiorespiratory failure. As ECMO technology advances, portability has become an important design consideration for transport and emergency applications. The OASSIST ECMO System is the first portable ECMO system developed in China and has demonstrated satisfactory safety and biocompatibility in preclinical studies. The present study aimed to evaluate its initial clinical safety, efficacy, and device performance in a first-in-human setting.

From December 2021 to September 2022. This first-in-human study involved 31 patients receiving ECMO support (21 VA-ECMO and 10 VV-ECMO) among 10 medical centers. The study duration was. Primary efficacy endpoints were survival rates at 24 h and 7 days after ECMO weaning, while secondary efficacy endpoints included device performance parameters and necessary patient-level data. The safety endpoints are mainly the monitoring of adverse events related to the test device.

Baseline demographic characteristics included a mean age of 58.03 ± 15.17 years, and 61.3% male. Mean ECMO support duration was 102.58 ± 89.88 h. Among the 31 patients enrolled, 83.9% (n = 26) survived both 24 h and 7 days after ECMO weaning. The VA-ECMO group had a 24-hour and 7-day survival rate of 85.7%, and the VV-ECMO group had 80.0%. 6 (19.4%) patients experienced bleeding events. Oxygenator replacement events were limited to 1 extensive thrombus formation within the oxygenator. There were 19 serious adverse events, including one case of lower limb necrosis that was adjudicated as possibly related to the test device; retrospective review suggested that this event occurred in the setting of pre-existing limb ischemia and may have been aggravated after ECMO cannulation. Performance metrics demonstrated the stable operation of the OASSIST ECMO System, and no major issues with the test device were noted.

This first in-human, multi-center, clinical trial demonstrated positive outcomes in clinical efficacy and safety of OASSIST ECMO System in providing mechanical cardiopulmonary support in patients cardiorespiratory failure.