HYbrid RObotic Surgery in Gynecology
The purpose of this clinical investigation is to evaluate the safety and performance of ROB and its corresponding ElectroSurgical Endoscopic instruments and Non-ElectroSurgical Endoscopic instruments (ESE and NESE instruments respectively) and accessories in patients with the indication of robot assisted laparoscopic Hysterectomy, Hysterectomy and Salpingectomy or Hysterectomy and Salpingectomy and Oophorectomy and when it applies Lysis of Adhesions, Lymphadenectomy and Sentinel lymph node biopsy (SLNB). HYROS-GYN is a confirmatory study in which the hypothesis of the primary endpoint is that the ESE/NESE instruments perform as intended when controlled by ROB which operates exclusively under surgeon's orders. It will include the data collected up to 30 days post-surgery.
- Subjects with a gynecological indication for a laparoscopic total hysterectomy... [+2]
- Pregnant or breastfeeding women at the time of the surgery [+6]