Hugoâ„¢ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology) (NCT07120945) | Clinical Trial Compass
RecruitingNot Applicable
Hugoâ„¢ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
United States70 participantsStarted 2025-08-28
Plain-language summary
The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugoâ„¢ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for cancer.
Who can participate
Age range22 Years
SexFEMALE
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Inclusion criteria
✓. 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
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.