Clinical trial · Interventional
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)
NCT07120945CI-TRIAL-00113306Embrace Gynactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomyosis of Uterus | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometriosis | — | UNRESOLVED | — |
| Menstrual Disorders | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
| Uterine Fibroids (UF) | Uterine Corpus Leiomyoma | ALIAS | 0.85 |
| Uterine Prolapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic Assisted-Surgery (RAS) Hysterectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic-Assisted Surgery (RAS) Hysterectomy Procedures
- description
- Patients indicated for Robotic-Assisted Surgery (RAS) for hysterectomy procedures (radical, modified radical, or total hysterectomy), inclusive of subjects being treated for malignancies.
- interventionNames
- Device: Robotic Assisted-Surgery (RAS) Hysterectomy
Primary outcomes (1)
- measure
- Surgical success rate
- timeFrame
- Intraoperative
- description
- 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.
Secondary outcomes (7)
- measure
- Operative time
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.