Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
Embrace Gyn
A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
1 other identifier
interventional
70
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2025
CompletedFirst Posted
Study publicly available on registry
August 13, 2025
CompletedStudy Start
First participant enrolled
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2031
ExpectedMarch 6, 2026
March 1, 2026
6 months
July 31, 2025
March 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical success rate
Surgical success rate is the procedure utilizing Hugo™ as outlined in the preoperatively defined surgical plan without conversion to an alternative robotic-assisted system, laparoscopy, or open surgery.
Intraoperative
Secondary Outcomes (7)
Operative time
Intraoperative
Hospital length of stay
From procedure to discharge, through approximately 30 days
Major complication rate
30 Days
Complication rate
30 Days
Rate of intraoperative adverse events
Intraoperative
- +2 more secondary outcomes
Study Arms (1)
Robotic-Assisted Surgery (RAS) Hysterectomy Procedures
EXPERIMENTALPatients indicated for Robotic-Assisted Surgery (RAS) for hysterectomy procedures (radical, modified radical, or total hysterectomy), inclusive of subjects being treated for malignancies.
Interventions
Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (5)
Ascension St. Vincent's Riverside
Jacksonville, Florida, 32204, United States
The University of South Florida
Tampa, Florida, 33606, United States
Duke University
Durham, North Carolina, 27710, United States
Allegheny Health Network - West Penn
Pittsburgh, Pennsylvania, 15224, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emma Rossi, MD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2025
First Posted
August 13, 2025
Study Start
August 28, 2025
Primary Completion
February 25, 2026
Study Completion (Estimated)
May 1, 2031
Last Updated
March 6, 2026
Record last verified: 2026-03