Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)

Korábbi kezelés

• Patient for whom minimally invasive surgery is contraindicated as determined by the Investigator.
• Patients with comorbidities or medical characteristics which would preclude the surgical procedure in the opinion of the Investigator.
• Patients diagnosed with a bleeding disorder and/or who cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
• Patients who are pregnant at the time of the surgical procedure.
• Patients who have participated or are currently participating in an investigational drug or in a device research study that may interfere with this study in the opinion of the Investigator.

Más betegség

• Patients with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia at physicians' discretion.
• Patients with a pre-surgical diagnosis of recurring cancer and gross metastatic conditions are excluded.
  • For cervical cancer, only patients with Stages 1a1, 1a2, 1b1, may be included, and within these stages, II. Eligibility is further restricted to those with Stage IB1 tumors less than 2 cm (on MRI) and less than 10 mm stromal invasion on excisional biopsy, or less than 50% cervical stromal invasion (on MRI).
  • All other cervical cancer stages are excluded from the study.
• Patients with disease spread out of the pelvis requiring surgical intervention with surgical expertise outside of the gynecological space, with the exception of para-aortic lymph node dissection, as determined by the investigator.

Egyéb

• Patients with an estimated life expectancy of less than 6 months as determined by Investigator
• Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity).
• Patients who have a body mass index (BMI) > 44.1 kg/m2

• Adult patients (age ≥ 22 years) as required by local law
• Patients indicated for a hysterectomy (radical, modified radical, or total hysterectomy) inclusive of subjects being treated for malignancies with the Hugo™ RAS system
• Patient is an acceptable candidate for a fully robotic-assisted surgical procedure, a laparoscopic surgical procedure, and an open surgical procedure
• The patient is willing to participate and consents to participate, as documented by a signed and dated informed consent form