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

Summary

The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugo™ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for cancer.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient for whom minimally invasive surgery is contraindicated as determined by the Investigator.
2. Patients with comorbidities or medical characteristics which would preclude the surgical procedure in the opinion of the Investigator.
3. Patients with an estimated life expectancy of less than 6 months as determined by Investigator
4. 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
5. Patients who are pregnant at the time of the surgical procedure.
6. Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity).
7. 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.
8. Patients with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia at physicians' discretion.
9. Patients with a pre-surgical diagnosis of recurring cancer and gross metastatic conditions are excluded.

   I. 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).

   III. All other cervical cancer stages are excluded from the study.
10. 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.
11. Patients who have a body mass index (BMI) \> 44.1 kg/m2

Conditions10

Locations5 sites

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