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 (5) 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
RECRUITING
Jacksonville
The University of South Florida
RECRUITING
Tampa
North Carolina
Duke University
RECRUITING
Durham
Pennsylvania
Allegheny Health Network - West Penn
RECRUITING
Pittsburgh
Washington
Swedish Medical Center
RECRUITING
Seattle
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