Actively Recruiting

Phase Not Applicable
Age: 22Years +
FEMALE
NCT07120945

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

Led by Medtronic - MITG · Updated on 2026-03-06

70

Participants Needed

5

Research Sites

296 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 22Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (age 223 22 years) as required by local law
  • Patients indicated for a hysterectomy (radical, modified radical, or total hysterectomy) including those treated for malignancies with the Hugo174 RAS system
  • Patient is a suitable candidate for robotic-assisted, laparoscopic, and open surgical procedures
  • Patient is willing and able to provide signed informed consent
Not Eligible

You will not qualify if you...

  • Minimally invasive surgery is contraindicated as determined by the Investigator
  • Comorbidities or medical conditions precluding surgery as judged by the Investigator
  • Estimated life expectancy less than 6 months
  • Bleeding disorder or inability to stop anticoagulants before surgery per surgeon discretion
  • Pregnancy at the time of surgery
  • Vulnerable populations such as prisoners or those lacking mental capacity
  • Participation in other investigational drug or device studies interfering with this study
  • Active infections such as pneumonia, urinary tract infection, cellulitis, or bacteremia
  • Presurgical diagnosis of recurring cancer with gross metastatic disease (except certain early-stage cervical cancers)
  • Disease spread outside the pelvis requiring non-gynecological surgical expertise (except para-aortic lymph node dissection)
  • Body mass index (BMI) greater than 44.1 kg/m2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Ascension St. Vincent's Riverside

Jacksonville, Florida, United States, 32204

Actively Recruiting

2

The University of South Florida

Tampa, Florida, United States, 33606

Actively Recruiting

3

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

4

Allegheny Health Network - West Penn

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

5

Swedish Medical Center

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

R

Rachel Liddicoat

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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