Purpose of this Study
In this study, people will be placed into one of two groups by chance, like flipping a coin. One group will have a device called ECLIPSIUM used to hold a mesh in place during hernia surgery. The other group will have the mesh held in place with tacks. About half of the people will be in each group.
Taking part in this study lasts about thirteen months. People will have seven planned study visits. These include a screening visit before surgery, the hernia repair surgery itself, a phone call or visit the day after surgery to ask about pain, and four in person visits at one month, three months, six months, and twelve months after surgery. At these visits, people will answer questions about their recovery and fill out questionnaires.
Who Can Participate?
Eligibility
People can join this study if they are 22 years old or older and have a type of belly hernia in the middle of the abdomen, the belly button area, or from a past surgery. They must also be scheduled to have a laparoscopic hernia repair, which is a surgery done through small openings using special tools.
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?
Description
This study is testing a new medical device called the ECLIPSIUM System. This device is not yet approved by the FDA. The goal of the study is to find out how safe ECLIPSIUM is and how well it works to help keep a hernia from coming back. Researchers will compare ECLIPSIUM to tacks, which are commonly used now to hold mesh in place during hernia surgery.
Locations
Duke Regional Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
Principal Investigator
Jin
Yoo
Protocol Number
PRO00119546
NCT ID
NCT07277946
Phase
N/A
Enrollment Status
Pending Open to Enrollment