ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
Stopped: Surgical complications arose early in the study, mainly due to patient complexity, not to study device or implantation. Despite refining protocol to exclude highly complex patients, these issues persisted, leading to the study's early termination.
France32 participantsStarted 2019-09-18
Plain-language summary
Interventional, prospective, multicenter, post-marketing clinical follow-up study.
After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health.
As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject has provided informed consent.
. Subject is ≥ 18 years of age at the time of consent.
. Subject will be undergoing an elective midline laparotomy.
. Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include:
. High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism
. Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI \< 35; ii.Age \> 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.
. Subject for which the device is used outside the product IFU, including;
. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
. Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics
. Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).
. Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.
. Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.
. Subject has participated in an investigational drug or device research study within 30 days of enrollment.