Preclinical Safety Evaluation of the LapBox Power Tissue Containment System Under Simulated Worst-Case Conditions in...

Background/NeedUncontained power morcellation during laparoscopic gynecologic surgery risks intra-abdominal dissemination of benign or malignant tissue, a significant safety concern highlighted by FDA warnings. This has created a critical need for robust and reliable tissue containment systems that can be easily integrated into surgical workflows to mitigate this risk.Methodology and device descriptionThe LapBox Power Tissue Containment System is a single-use device featuring a dual-walled inflatable chamber designed to create a secure environment for morcellation. We conducted a Good Laboratory Practice (GLP)-compliant toxicology study in three female domestic pigs to assess its safety under simulated worst-case conditions. The device was inserted laparoscopically, and the internal dual-walled chamber of the device was inflated to a high pressure (∼160 mmHg) to simulate a localized worst-case compressive scenario, while the overall intra-abdominal insufflation was maintained at a standard 15 mmHg. Postoperative monitoring included clinical observation, bloodwork, and, at day 13, necropsy and histopathology.Preliminary ResultsAll procedures were completed without mortality, morbidity, or device-related complications. The LapBox maintained full structural integrity. Postoperative clinical, hematological, and biochemical parameters showed no adverse effects. Gross necropsy and detailed histopathology confirmed the absence of device-related ischemia, necrosis, thrombosis, or foreign-body reaction.Current statusThis preclinical study demonstrates that the LapBox Power system has an excellent safety profile and biocompatibility, even under extreme conditions. The device is ready for the next stage of evaluation. These findings support its translational potential and warrant further investigation in human clinical studies to confirm its safety and efficacy.