Purpose of this Study
We are doing this study to evaluate the safety and performance of a medical technology called the Medtronic Hugo® RAS system (the study device) in hernia repair robotic assisted surgery (RAS) procedures.
Who Can Participate?
Eligibility
Adults ages 22+ who are scheduled to have an inguinal or ventral robotic hernia procedure.
For more information, contact the study team at <a href= "mailto: shawn.greene@duke.edu">shawn.greene@duke.edu.</a>
For more information, contact the study team at <a href= "mailto: shawn.greene@duke.edu">shawn.greene@duke.edu.</a>
Age Range
22-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, it will include up to 6 visits:<ul>
<li>A screening visit to make sure you are eligible to take part</li>
<li>A surgical visit to have your procedure with the study device</li>
<li>A 30-day follow-up visit to see how you are doing</li>
<li>A 3-month follow-up visit to see how you are doing</li>
<li>A 1 year follow-up visit to see how you are doing</li>
<li>A 2 year follow-up visit to see how you are doing</li></ul>
<li>A screening visit to make sure you are eligible to take part</li>
<li>A surgical visit to have your procedure with the study device</li>
<li>A 30-day follow-up visit to see how you are doing</li>
<li>A 3-month follow-up visit to see how you are doing</li>
<li>A 1 year follow-up visit to see how you are doing</li>
<li>A 2 year follow-up visit to see how you are doing</li></ul>
Locations
Duke Regional Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A prospective, multi-center, single-arm study of the Medtronic HugoTM Robotic Assisted Surgery (RAS) System in Inguinal and Ventral Hernia Repair Surgery
Principal Investigator
Jacob
Greenberg
Protocol Number
PRO00114154
NCT ID
NCT06445504
Phase
N/A
Enrollment Status
Open to Enrollment