LAUSR

Study Objective Clinical evaluation of LapBox, a novel tissue containment system for power and manual morcellation in laparoscopic gynecological surgery. Design Described cases were performed as part of an ongoing First in Human prospective, open label, multi-center, non-randomized study. Primary safety endpoint was non-occurrence of device-related adverse events. Primary performance endpoint was containment integrity (leak testing) following procedure. Secondary endpoints were ease of use, intra or post-operative complications, procedure time, hospitalization duration, specimen weight. Setting The LapBox extraction device is inserted using a dedicated delivery system. The organ is then encapsulated, and double wall chamber inflated. Chamber opening is extracted offering direct access and view to the contained organ within the inflated abdomen. Patients or Participants Patients undergoing elective laparoscopic myomectomy or hysterectomy requiring morcellation. Interventions Patient #1 (age 33), underwent laparoscopic myomectomy with manual morcellation of a 37g myoma Patient #2 (age 44), underwent laparoscopic hysterectomy with power and manual morcellation of a 670g uterus. Measurements and Main Results No adverse events were recorded. Leak test was performed post procedure demonstrating device integrity. Peritoneal wash performed before and after LapBox use showed no malignancy. For both cases, device insertion, chamber deployment, port placement, organ capture, and device retraction were scored by the investigator in post-procedure questionnaires as of synovial sarcoma. In two weeks time. Some difficulty was noted in chamber extraction containing debris from the morcellated organ. Conclusion Presented data is based on first time use of a new surgical device. Initial data indicates that the device works as intended. Additional cases are required in order to generate more experience and identify potential areas for improvement.