A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
Medtronic - MITG
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.
Description
This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).
Eligibility
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
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 surger…
Interventions
- DeviceRobotic Assisted-Surgery (RAS) Hysterectomy
Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system.
Locations (5)
- Ascension St. Vincent's RiversideJacksonville, Florida
- The University of South FloridaTampa, Florida
- Duke UniversityDurham, North Carolina
- Allegheny Health Network - West PennPittsburgh, Pennsylvania
- Swedish Medical CenterSeattle, Washington