UNITE IDE: Hernia Repair with ECLIPSIUM - Clinical Trial
What is the 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.
Hernia repair
Who Can Participate in the Study?
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.
What is Involved?
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.
Study Details
