RecruitingNot ApplicableNCT07120945

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

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


Sponsor

Medtronic - MITG

Enrollment

70 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the Hugo robotic-assisted surgery (RAS) system for gynecological surgeries, including hysterectomies (removal of the uterus) for both benign conditions and cancers. The Hugo system is a newer robotic surgical platform, and this trial aims to assess its safety and performance in gynecology. **You may be eligible if...** - You are 22 or older (as required by local law) and scheduled for a hysterectomy (total, modified radical, or radical) - Your hysterectomy may be for a benign condition or gynecologic cancer - You are an appropriate candidate for both robotic-assisted and open surgical approaches - You have provided written informed consent **You may NOT be eligible if...** - You are not a candidate for robotic, laparoscopic, or open surgery - You have severe uncontrolled medical conditions that make surgery too risky - You are unwilling to participate - You are under 22 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERobotic Assisted-Surgery (RAS) Hysterectomy

Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system.


Locations(5)

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

Swedish Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07120945


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