The Aquilex™ Fluid Control System Performance during Hysteroscopic Procedures

Abstract

This study assessed the performance and ease of use of the automated Aquilex™ fluid control system compared to manual fluid management during hysteroscopic procedures. Non-randomized, comparative study. One obstetrics and gynecology practice in the U.S. 21 patients, 18 to 65 years of age, with an indication for hysteroscopy and/or a therapeutic hysteroscopic procedure. Hysteroscopic procedures, including polypectomy or myomectomy using the MyoSure® tissue removal device (n = 11), diagnostic hysteroscopy (n = 8), and the Adiana® permanent contraception procedure (n = 2), were performed according to standard medical practice using the Aquilex system with concurrent manual fluid measurements. Manual and automated calculations of the total fluid volume used and the final fluid deficit were compared for the total sample of procedures (n = 21). Intrauterine pressure ranges were recorded. Physician and nurse satisfaction with the Aquilex system was evaluated using a 5 point Likert scale. Preliminary results showed strong agreement between the Aquilex system and manual measurements of the mean fluid volume used (intraclass correlation coefficient (ICC): 0.99) and the final fluid deficit (ICC: 0.91). The mean low and high intrauterine pressures for all procedures were 81.0 ± 13.7 mmHg and 108.1 ± 24.2 mmHg, respectively. The Aquilex system performance was rated as excellent for ease of tubing set up, system set up and fluid canister exchange, and rated above average for distention and visualization. In all cases, there was agreement or strong agreement that the Aquilex system improved the ease of performing hysteroscopic procedures compared to manual fluid management. There were no adverse events. These results demonstrate physician and nurse satisfaction with the Aquilex fluid control system. There was strong agreement between the Aquilex system and manual fluid measurements during hysteroscopic procedures.