A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 22
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Ascension St. Vincent's Riverside
NOT_YET_RECRUITING
Jacksonville
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
Pennsylvania
Allegheny Health Network - West Penn
RECRUITING
Pittsburgh
Contact Information
Primary
Rachel Liddicoat
rachel.liddicoat@medtronic.com
7632041723
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2031-05
Participants
Target number of participants: 70
Treatments
Experimental: Robotic-Assisted Surgery (RAS) Hysterectomy Procedures
Patients indicated for Robotic-Assisted Surgery (RAS) for hysterectomy procedures (radical, modified radical, or total hysterectomy), inclusive of subjects being treated for malignancies.
Related Therapeutic Areas
Sponsors
Leads: Medtronic - MITG