Uterine Fibroids (UF)Embrace GynNCT07120945
Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
A study testing Robotic Assisted-Surgery (RAS) Hysterectomy in people with Uterine Fibroids (UF) and Menstrual Disorders, run by Medtronic - MITG at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Uterine Fibroids (UF), Menstrual Disorders, Adenomyosis of Uterus
- What is being tested?
- Robotic Assisted-Surgery (RAS) Hysterectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Aug 2025to May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 22 years) as required by local law
- Patients indicated for a hysterectomy (radical, modified radical, or total hysterectomy) inclusive of subjects being treated for malignancies with the Hugo™ RAS system
- Patient is an acceptable candidate for a fully robotic-assisted surgical procedure, a laparoscopic surgical procedure, and an open surgical procedure
- The patient is willing to participate and consents to participate, as documented by a signed and dated informed consent form
Who cannot join
- Patient for whom minimally invasive surgery is contraindicated as determined by the Investigator.
- Patients with comorbidities or medical characteristics which would preclude the surgical procedure in the opinion of the Investigator.
- Patients with an estimated life expectancy of less than 6 months as determined by Investigator
- 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
- Patients who are pregnant at the time of the surgical procedure.
- Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity).
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- 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.
- Patients with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia at physicians' discretion.
- Patients with a pre-surgical diagnosis of recurring cancer and gross metastatic conditions are excluded.
- 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).
- All other cervical cancer stages are excluded from the study.
- 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.
- Patients who have a body mass index (BMI) > 44.1 kg/m2
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Duke University
Durham, North Carolina, 27710
Ascension St. Vincent's Riverside
Jacksonville, Florida, 32204
Allegheny Health Network - West Penn
Pittsburgh, Pennsylvania, 15224
Swedish Medical Center
Seattle, Washington, 98104
The University of South Florida
Tampa, Florida, 33606
About this study
Official title: A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
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.
Read the detailed description
This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).
- Conditions
- Uterine Fibroids (UF), Menstrual Disorders, Adenomyosis of Uterus, Endometriosis, Uterine Prolapse, Precancerous/Nonmalignant Condition
- Being tested
- Robotic Assisted-Surgery (RAS) Hysterectomy
- Medical subject headings
- Leiomyoma, Menstruation Disturbances, Adenomyosis, Endometriosis, Uterine Prolapse, Precancerous Conditions, Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted-Surgery (RAS) HysterectomyDevice
Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Surgery (RAS) Hysterectomy Procedures | Experimental | Patients indicated for Robotic-Assisted Surgery (RAS) for hysterectomy procedures (radical, modified radical, or total hysterectomy), inclusive of subjects being treated for malignancies. Receives: Device: Robotic Assisted-Surgery (RAS) Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate
Surgical success rate is the procedure utilizing Hugo™ as outlined in the preoperatively defined surgical plan without conversion to an alternative robotic-assisted system, laparoscopy, or open surgery.
Measured: Intraoperative
Secondary outcomes (7)
Operative time
Time from skin incision to skin closure
Measured: Intraoperative
Hospital length of stay
Hospital length of stay from the date of the procedure to discharge
Measured: From procedure to discharge, through approximately 30 days
Major complication rate
Overall rate of subjects with one or more complication (Clavien-Dindo Grade III or higher) related to study device and/or procedure, from the first incision through 30 days post-procedure.
Measured: 30 Days
Complication rate
Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher) related to study device and/or procedure, from the first incision through 30 days post-procedure.
Measured: 30 Days
Rate of intraoperative adverse events
Rate of intraoperative adverse events related to study device and/or procedure from first incision through skin closure.
Measured: Intraoperative
Rate of readmission
Rate of readmission within 30 days due to device and/or procedure related adverse events.
Measured: 30 Days
Rate of therapy-specific adverse events
Rate of complications due to the study device and/or procedure.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start28 Aug 2025
- Primary completion25 Feb 2026
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids (UF)Studies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Rossi, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120945
- Sponsor's protocol ID
- MDT24040
- Acronym
- Embrace Gyn
- Status last verified
- May 2026
- First submitted
- 31 Jul 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
- ClinicalTrials.gov ID
- NCT07120945
- Acronym / sponsor ID
- Embrace Gyn / MDT24040
- Conditions
- Uterine Fibroids (UF), Menstrual Disorders, Adenomyosis of Uterus, Endometriosis, Uterine Prolapse, Precancerous/Nonmalignant Condition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- May 2031 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Surgery (RAS) Hysterectomy Procedures | Experimental | Device: Robotic Assisted-Surgery (RAS) HysterectomyPatients indicated for Robotic-Assisted Surgery (RAS) for hysterectomy procedures (radical, modified radical, or total hysterectomy), inclusive of subjects being treated for malignancies. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age ≥ 22 years) as required by local law
- Patients indicated for a hysterectomy (radical, modified radical, or total hysterectomy) inclusive of subjects being treated for malignancies with the Hugo™ RAS system
- Patient is an acceptable candidate for a fully robotic-assisted surgical procedure, a laparoscopic surgical procedure, and an open surgical procedure
- The patient is willing to participate and consents to participate, as documented by a signed and dated informed consent form
Key exclusion criteria (13 listed)
- Patient for whom minimally invasive surgery is contraindicated as determined by the Investigator.
- Patients with comorbidities or medical characteristics which would preclude the surgical procedure in the opinion of the Investigator.
- Patients with an estimated life expectancy of less than 6 months as determined by Investigator
- 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
- Patients who are pregnant at the time of the surgical procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Assisted-Surgery (RAS) HysterectomyPatients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system. | Device | Robotic-Assisted Surgery (RAS) Hysterectomy Procedures |
Primary outcome
Surgical success rate
Time frame: Intraoperative
Surgical success rate is the procedure utilizing Hugo™ as outlined in the preoperatively defined surgical plan without conversion to an alternative robotic-assisted system, laparoscopy, or open surgery.
7 secondary outcomes
Operative time
Time frame: Intraoperative
Hospital length of stay
Time frame: From procedure to discharge, through approximately 30 days
Major complication rate
Time frame: 30 Days
Complication rate
Time frame: 30 Days
Rate of intraoperative adverse events
Time frame: Intraoperative
Rate of readmission
Time frame: 30 Days
Rate of therapy-specific adverse events
Time frame: 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Rossi, MD principal investigator
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Assisted-Surgery (RAS) Hysterectomy in people with Uterine Fibroids (UF) and Menstrual Disorders, run by Medtronic - MITG at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.