Clinical Validation Study of the Eximis CS (Contained Segmentation) System

Exclusion Criteria

• •Subject is post-menopausal, defined as amenorrhea \>12 months in the absence of ovulation suppression.
• •Known or suspected malignancy of gynecological origin as determined by standard clinical practice.
• •Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision.
• •Hemoglobin \< 8 g/dl within 30 days prior to surgery. Subject has a current history of undiagnosed genital bleeding Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator).
• •Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System.
• •Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or chlorinated polyvinyl chloride.
• •Concurrent participation in another therapeutic or interventional clinical trial with investigational pharmaceutical agent(s) or medical device(s) that could impact evaluation of this study as determined by the Investigator.
• •Inability to comply with the study procedures or follow-up in the opinion of the investigator.
• •Subject is pregnant.
• •Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site exceeds 6 cm.