Overview
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.
Description
The ROB-Bitrack System is 4-arms on demand open and portable robotic platform indicated to be used during general abdominal laparoscopic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for endoscopic visualization and manipulation of tissue. The HYROS-GYN clinical investigation will evaluate the safety and performance of ROB and its corresponding ESE and NESE Endoscopic instruments and accessories. It will include 9 patients and will be conducted in two sites, with a single arm, open-label, and non-randomized design,. The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 7-Days, 14-Days and 30-Days Follow-up visits . The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic total hysterectomy, with or without salpingectomy and/or oophorectomy.The expected duration of the study is 6 months from the first patient enrolled to the last visit of the last patient follow up.
Eligibility
Inclusion Criteria:
- \- Subjects with a gynecological indication for a laparoscopic total hysterectomy, with or without salpingectomy and/or oophorectomy (i.e., removal of one or both fallopian tubes and/or ovaries).
- \- Subjects that additionally to the hysterectomy procedure may require sentinel lymph node biopsy (SLN) and/or pelvic lymphadenectomy (LND) according to investigator criteria.
- \- Ability and willingness to comply with all study requirements to be evaluated for each study visit
Exclusion Criteria:
- \- Pregnant or breastfeeding women at the time of the surgery
- \- Subjects with a medical indication for radical hysterectomy (e.g., suspected or confirmed invasive cervical cancer or other conditions requiring radical surgical management).
- \- Subjects who had been treated with radiation therapy previous to the surgery.
- \- Subjects with uterine enlargement \>8 cm for which morcellation would not allow for vaginal removal.
- \- Subjects with a BMI ≥ 40
- \- Subjects not suitable to undergo MIS/MIRS, according to medical criteria:
- with severe concomitant illness (e.g., severe cardiopulmonary, corornary artery disease or bleeding disorders)
- that have been submitted to multiple previous abdominal surgeries with multiple adhesions . 7- Subjects admitted to the hospital due to an emergency situation.
8 - Subjects with untreated active infection 9 - Subject with any contraindication for the use of Bitrack Sytem \& ESE/NESE Instruments and/or known allergy to some of the device components (i.e., stainless steel, etc.) 10 - Subjects with life expectancy inferior to 3 months 11 - Subjects with abuses of active substances or with uncontrolled psychiatric disorders 12 - Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system. 13 - Inability to adhere to study-related procedures 14 - Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow up requirements
