NCT07120945 Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
| NCT ID | NCT07120945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic - MITG |
| Condition | Uterine Fibroids (UF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2026-02-25 |
Trial Parameters
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Brief 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 Criteria
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