IRB Study Number 24-1155
Status Recruiting
Locations Cleveland Clinic Weston Hospital , Cleveland Clinic Main Campus
Institute Digestive Disease & Surgery Institute
Description
This study is for adults who are having elective minimally invasive surgery to repair a ventral (abdominal wall) hernia using mesh.
During your surgery, the surgeon will use a motorized device called MaxTack™ to place small absorbable tacks that fix the mesh to the inside of the abdominal wall. This device is already FDA-cleared for this use.
The purpose of the study is to see how safe and effective this fixation device is in real-world hernia repairs by looking at:
wound healing and surgical site problems (such as fluid collections, bleeding, or infection),
hernia recurrence,
pain at the hernia site,
quality of life after surgery, and
hospital stay and need for re-operation.
If you take part, your hernia surgery and mesh repair are standard of care. The study adds extra data collection, brief questionnaires about pain and quality of life, and planned follow-up visits around 1 month, 3 months, and 12 months after surgery. Imaging (CT, ultrasound, MRI) is only done if your doctor feels it is needed as part of your usual care.
Inclusion Criteria
Age 18 years or older at the time of consent
Able and willing to sign informed consent and follow study visits
Scheduled for an elective, single-stage repair of a primary or incisional ventral hernia
Surgery planned as a minimally invasive ventral hernia repair (laparoscopic or robotic) using mesh
The surgeon plans to use the MaxTack™ Motorized Fixation Device to fix the mesh
The surgeon plans to use a Medtronic/Covidien mesh according to its Instructions for Use
Expected to have a clean (Class I) surgical wound at the time of surgery
Exclusion Criteria
Pre-operative exclusions
Emergency operation (for example, strangulated hernia or life-saving surgery)
History of 3 or more prior hernia repairs
Existing mesh already in the exact space where the new mesh needs to be placed
Planned or expected additional surgery that could interfere with the study repair
Known allergy to PGLA (poly[glycolide-co-L-lactide]) or to any component of the planned mesh
Any active systemic or local infection at the time of surgery
Body Mass Index (BMI) > 45 kg/m²
Estimated life expectancy < 3 years in the opinion of the investigator
Pregnant or planning pregnancy during the study period
Currently in, or planning to enter, another investigational drug or device study that could interfere with results
Any condition that, in the investigator’s opinion, would make participation unsafe or make follow-up unlikely
Already enrolled, or previously enrolled, in this study
Intra-operative exclusions (confirmed during surgery)
MaxTack™ tacks are not used to fix the mesh
A non-Medtronic mesh is used
More than one piece of mesh is required to repair the hernia
Surgical wound is Class II, III, or IV (clean-contaminated, contaminated, or dirty/infected)
ASA physical status 4, 5, or 6 at the time of surgery
The hernia defect cannot be closed
The repair must be done as a multi-stage procedure
The operation must be converted from minimally invasive to open surgery
