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

Running, not enrolling · Not applicable

Conditions studied: Uterine Fibroids (UF), Menstrual Disorders, Adenomyosis of Uterus, Endometriosis, Uterine Prolapse, Precancerous/Nonmalignant Condition, Cervical Cancer, Endometrial Cancer, Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT07120945

Run by

Medtronic - MITG

People needed

70

Starts

2025-08-28

Expected to finish

2031-05-01

Last updated by the study team

2026-06-02

Who can join

Age: 22 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ascension St. Vincent's Riverside — Jacksonville, Florida, United States
• The University of South Florida — Tampa, Florida, United States
• Duke University — Durham, North Carolina, United States
• Allegheny Health Network - West Penn — Pittsburgh, Pennsylvania, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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