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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.
Full description
This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).
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Inclusion criteria
Exclusion criteria
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 with an estimated life expectancy of less than 6 months as determined by 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 are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity).
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.
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.
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.
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.
Patients who have a body mass index (BMI) > 44.1 kg/m2
Primary purpose
Allocation
Interventional model
Masking
70 participants in 1 patient group
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Central trial contact
Rachel Liddicoat
Data sourced from clinicaltrials.gov
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