Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
NCT ID: NCT07120945
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-08-28
2031-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Robotic-Assisted Surgery (RAS) Hysterectomy Procedures
Patients indicated for Robotic-Assisted Surgery (RAS) for hysterectomy procedures (radical, modified radical, or total hysterectomy), inclusive of subjects being treated for malignancies.
Robotic Assisted-Surgery (RAS) Hysterectomy
Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system.
Interventions
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Robotic Assisted-Surgery (RAS) Hysterectomy
Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system.
Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
FEMALE
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Emma Rossi, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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MDT24040
Identifier Type: -
Identifier Source: org_study_id