1. Evaluation of the performance, operability, and safety of Plasauto μ, a new type of machine for cell‐free and concentrated ascites reinfusion therapy, in a postmarketing clinical study
- Author
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Masao Kato, Sachie Yamada, Hitoshi Kanno, Hiromichi Matsushita, Ryoko Kawahara, Hiroki Hayashi, Yukio Yuzawa, Midori Hasegawa, Norio Nii, Yoshitaka Ishibashi, Atsushi Ohashi, Yoshifumi Hamasaki, Shigehisa Koide, Naotake Tsuboi, Kensei Yahata, and Akira Sugawara
- Subjects
Adult ,Male ,medicine.medical_specialty ,a new type of machine ,030232 urology & nephrology ,Cell free ,030204 cardiovascular system & hematology ,Gastroenterology ,cell‐free and concentrated ascites reinfusion therapy ,Clinical study ,03 medical and health sciences ,0302 clinical medicine ,Recovery rate ,Negatively associated ,Internal medicine ,Ascites ,Product Surveillance, Postmarketing ,medicine ,Humans ,Adverse effect ,Aged ,Total protein ,Aged, 80 and over ,Cell-Free System ,business.industry ,Albumin ,Original Articles ,Equipment Design ,Hematology ,Middle Aged ,post‐marketing clinical study ,recovery rate ,Nephrology ,Original Article ,Female ,medicine.symptom ,business ,Filtration - Abstract
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.
- Published
- 2021
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