Evaluation of the performance, operability, and safety of Plasauto μTM , a new type of machine for cell-free and concentrated ascites reinfusion therapy (CART), in a post-marketing clinical study.

INTRODUCTION Cell-free and concentrated ascites reinfusion therapy (CART) is performed by collecting the ascites from the patient, followed by filtration and concentration. Thereafter, concentrated cell-free ascites is reinfused into the patient intravenously. The new type of machine, Plasauto μTM , for managing the process of CART was launched onto the market. METHODS We have evaluated the machine through post-marketing clinical study in seventeen patients with malignant ascites. RESULTS The amounts of original and concentrated ascites were 3,673 ± 1,920 g and 439 ± 228 g, respectively. Recovery rates were acceptable regarding values of total protein, albumin, and immunoglobulin G that were 55.6% ±17.3 %, 60.2% ±20.8%, and 58.2% ±20.5%, respectively. Recovery rates were positively associated with amounts of original ascites and negatively associated with total protein concentration. No adverse events related to the machine were observed. CONCLUSION The new type of machine showed preferable performance in processing malignant ascites. This article is protected by copyright. All rights reserved.