New robot could transform hysterectomy surgery
NCT ID NCT07120945
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new robotic system, the Medtronic Hugo™, for performing hysterectomies. It includes 70 patients with conditions like uterine fibroids, endometriosis, or certain cancers. The goal is to see if the robot is safe and can complete the surgery without switching to other methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Medtronic Hugo™ Robotic-Assisted Surgery (RAS) system
- What this could lead to
- If successful, this could provide a new robotic option for hysterectomy, potentially improving surgical precision and recovery.
- What could go wrong
- This is an early-stage, single-arm study with only 70 participants, so results may not apply broadly. There are standard surgical risks like infection or complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allegheny Health Network - West Penn
Pittsburgh, Pennsylvania, 15224, United States
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Ascension St. Vincent's Riverside
Jacksonville, Florida, 32204, United States
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Duke University
Durham, North Carolina, 27710, United States
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Swedish Medical Center
Seattle, Washington, 98104, United States
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The University of South Florida
Tampa, Florida, 33606, United States
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- Can pulsed radiation extend life in metastatic cervical cancer?
- Appendix: the hidden driver of endometriosis pain?