IBC Oxford University Oral Abstract 42 - Interim results of prospective clinical trial: evaluation of the AEON endoscopic powered stapler handle and reload in primary sleeve gastrectomy

Abstract Background Bariatric surgery is a leading intervention for obesity, with sleeve gastrectomy being the most popular due to its low morbidity and mortality. However, complications like staple line bleeding remain significant. Advanced stapling technologies that enhance safety, ease-of-use, and hemostasis are crucial for next-generation devices. The AEON endoscopic stapler (Lexington Medical, MA, USA) was introduced to the market in 2018 and has been shown to be safe and effective in the approved indications as demonstrated by internal device testing, published animal studies1, 2, and clinical evaluations 3, 4, 5. Lexington Medical has developed a new stapling technology, the AEON Powered Stapling System. The prospective First-in-Man clinical trial was conducted to test the hypothesis that this new technology could enhance consistency and stability during firing, thereby reducing tissue trauma, improving hemostasis, and decreasing postoperative complications. Methods The objective of this prospective, single-arm, single-center study was to evaluate the clinical outcomes of patients undergoing primary sleeve gastrectomy procedures using the AEON Endoscopic Powered Stapler Handle and Reload (Fig. 1). The primary endpoint was to assess the percentage of patients experiencing postoperative staple line complications, namely bleeding or leaks, which required blood transfusion or revision surgery resulting from said complications. In addition, the hemostatic appearance of the staple line was analyzed using a visual analogue score (VAS), graded from 1 to 5 based on bleeding observed at the staple line 10 seconds after completion of resection (Fig. 2). Safety endpoints included evaluating device-related adverse events, serious adverse events, unanticipated adverse device effects, and revision surgeries. Results The study commenced in 2024. We present interim results of 30 consecutive patients who have completed the 3 weeks follow-up in Tables 1, 2. Discussion No intraoperative or postoperative complications were observed during the study. Bleeding Severity Scores were 1.03 + 0.183 on a 1–5 scale indicating that the staple lines were effectively free from bleeding. Figs 3, 4 provide two representative laparoscopic images captured during surgery with the powered handle. Compared to the AEON manual handle where calculated VAS scores in sleeve gastrectomy procedure were found to be 2.1 and 1.5 in published clinical studies 3, 5, the lower powered handle VAS scores support the hypothesis that the AEON Powered Stapling System which adjusts firing speed based on tissue thickness, further improves staple formation and delivers an even more hemostatic staple line than a manual stapler. This hypothesis should be validated with a larger sample size and two-arm powered prospective study. Conclusions The First-in-Man clinical study of the AEON Power Stapling System has demonstrated the device’s safety and effectiveness in performing primary sleeve gastrectomy procedures. The clinical results were notably excellent, particularly in relation to intraoperative and postoperative staple-line bleeding. It is hypothesized that the stapler’s intelligent functionality, specifically its ability to detect tissue thickness and automatically adjust firing speed to facilitate precise dissection, played a significant role in minimizing tissue trauma and contributed to the superior haemostasis, enhancing the overall surgical outcomes