Hugo Robotic-Assisted Hysterectomy for Gynecologic Conditions

A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)

This trial will test the Medtronic Hugo robotic system for performing hysterectomies in adults with fibroids, endometriosis, adenomyosis, menstrual disorders, uterine prolapse, and some cancers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 22 Years and up
• Sex: Female
• Sponsor: Medtronic - MITG (Industry-sponsored)
• Locations: 5 sites (Jacksonville, Florida and 4 other locations)
• Trial ID: NCT07120945 on ClinicalTrials.gov

What this trial studies

This interventional study will enroll up to 70 adult patients across up to five U.S. sites to use the investigational Medtronic Hugo robotic-assisted surgery (RAS) system during hysterectomy procedures. Participants may undergo total, modified radical, or radical hysterectomy, including cases for malignancy, and must be candidates for robotic, laparoscopic, and open surgery. The study will collect safety and performance data during the procedures and through the postoperative period. Outcomes will include device-related adverse events, procedural success, and perioperative metrics such as blood loss and recovery.

Who should consider this trial

Good fit: Adults aged 22 or older who need a hysterectomy and are acceptable candidates for robotic-assisted, laparoscopic, and open surgical approaches (including some cancer patients) are ideal candidates.

Not a fit: Patients for whom minimally invasive surgery is contraindicated, those with serious comorbidities or bleeding disorders, those who cannot stop anticoagulants, or those with a life expectancy under six months may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the Hugo RAS could provide a comparable or improved option for performing hysterectomies that may enable more precise surgery and faster recovery.

How similar studies have performed: Robotic-assisted hysterectomy with other platforms (such as the da Vinci system) is well established and has demonstrated safety and effectiveness, but the Hugo system is newer and has less gynecologic clinical data.

Eligibility criteria

Inclusion Criteria:

1. Adult patients (age ≥ 22 years) as required by local law
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:

1. Patient for whom minimally invasive surgery is contraindicated as determined by the Investigator.
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

Where this trial is running

Jacksonville, Florida and 4 other locations

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

Study contacts

• Principal investigator: Emma Rossi, MD — Duke University
• Study coordinator: Rachel Liddicoat

Conditions Uterine Fibroids; Menstrual Disorders; Adenomyosis of Uterus; Endometriosis; Uterine Prolapse; Precancerous/Nonmalignant Condition; Cervical Cancer; Endometrial Cancer