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NCT07120945 | RECRUITING | Uterine Fibroids (UF)

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

Medtronic - MITG

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.

Condition or disease

Uterine Fibroids (UF)

Menstrual Disorders

Adenomyosis of Uterus

Endometriosis

Uterine Prolapse

Precancerous/Nonmalignant Condition

Cervical Cancer

Endometrial Cancer

Ovarian Cancer

Intervention/treatment

Robotic Assisted-Surgery (RAS) Hysterectomy

Phase

NA

Detailed Description:

This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
Actual Study Start Date : 2025-08-28
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2031-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)

Location Details

NCT07120945

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Ascension St. Vincent's Riverside

Jacksonville, florida, United States, 32204

RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

RECRUITING

United States, Pennsylvania

Allegheny Health Network - West Penn

Pittsburgh, Pennsylvania, United States, 15224