RECRUITING

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

Conditions

Uterine Fibroids (UF)Menstrual Disorders Adenomyosis of Uterus Endometriosis Uterine Prolapse Precancerous/Nonmalignant Condition Cervical Cancer Endometrial Cancer Ovarian Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-28

Study Completion:2031-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07120945

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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. 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

Inclusion Criteria

Exclusion 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

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.
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

Contacts and Locations

Study Contact

Rachel Liddicoat

CONTACT

7632041723

rachel.liddicoat@medtronic.com

Principal Investigator

Emma Rossi, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Ascension St. Vincent's Riverside

Jacksonville, Florida, 32204

United States

Duke University

Durham, North Carolina, 27710

United States

Allegheny Health Network - West Penn

Pittsburgh, Pennsylvania, 15224

United States

Collaborators and Investigators

Sponsor: Medtronic - MITG

Emma Rossi, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-28

Study Completion Date2031-05

Study Record Updates

Study Start Date2025-08-28

Study Completion Date2031-05

Terms related to this study

Additional Relevant MeSH Terms

Uterine Fibroids (UF)
Menstrual Disorders
Adenomyosis of Uterus
Endometriosis
Uterine Prolapse
Precancerous/Nonmalignant Condition
Cervical Cancer
Endometrial Cancer
Ovarian Cancer