AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair

Launched by MEDTRONIC - MITG · Nov 26, 2024

Keywords

ClinConnect Summary

The AFFIX clinical trial is studying a new device called the MaxTack™ Motorized Fixation Device, which is used during minimally invasive surgery to repair ventral hernias. A ventral hernia occurs when tissue bulges through a weak spot in the abdominal muscles. This study aims to see how well the device works and how safe it is when fixing a special type of mesh to the tissue during the surgery.

To participate in this trial, you need to be at least 18 years old and undergoing a planned surgery for a ventral hernia. You should not have had multiple hernia repairs before or have any infections at the time of surgery. Participants can expect to follow a specific schedule for check-ups after the surgery to ensure everything is healing properly. This study is open to all genders and is currently recruiting participants. If you or a loved one are considering ventral hernia surgery, this trial may offer an opportunity to help advance medical knowledge while receiving care with the new device.

Gender

ALL

Eligibility criteria

• Preoperative Inclusion Criteria:
• • 1. Subject has provided informed consent (IC)
• • 2. Subject is 18 years of age or older at the time of consent
• • 3. Subject is able and willing to comply with the study requirements and follow-up schedule
• • 4. Subject is undergoing an elective, single-stage, primary or incisional ventral hernia repair
• • 5. Subject is undergoing minimally invasive ventral hernia repair procedure using the MaxTack™ Motorized Fixation Device
• • 6. Subject is undergoing minimally invasive ventral hernia repair procedure using a Medtronic (including Covidien) mesh that is intended to be used in compliance with the mesh Instructions for Use (IFU)
• • 7. Subject is expected to meet the criteria for a class I wound (clean) as defined by Centers for Disease Control and Prevention (CDC) classification
• Preoperative Exclusion Criteria:
• • 1. Subject is undergoing an emergency surgery (e.g., lifesaving procedures performed where subject is in imminent danger of death, strangulated hernia, etc.)
• • 2. Subject has history of 3 or more hernia repair procedures
• • 3. Subject has existing mesh in the space where the physician needs to apply the new mesh to be fixated with the MaxTack™ Motorized Fixation Device
• • 4. Subject is scheduled (or anticipated to be scheduled) for additional surgery, and subsequent surgery would jeopardize previous application of study treatment
• • 5. Subject has history of allergic reactions to Poly (Glycolide-co-L-lActide) (PGLA)
• • 6. Subject has history of allergic reactions to the components of the intended mesh
• • 7. Subject has any systemic or local ongoing infection at the time of the surgery
• • 8. Subject has a Body Mass Index (BMI) greater than 45 kg/m2
• • 9. Subject has life expectancy in the opinion of the investigator, of less than 3 years at the time of enrollment
• • 10. Subject is pregnant (as determined by standard site practices) or is planning to become pregnant during study duration period.
• • 11. Subject has participated or will participate in an investigational drug or device research study that would interfere with the results of this study
• • 12. Subject's participation in the study may jeopardize the safety or welfare of the subject, as determined by the investigator
• • 13. Subject is already enrolled or was previously enrolled in this study
• Intraoperative Exclusion Criteria:
• • 1. Subject did not receive the MaxTack™ Motorized Fixation Device tacks to fixate the mesh
• • 2. Subject did not receive a Medtronic (including Covidien) mesh
• • 3. Inability to comply with the mesh IFU
• • 4. Subject required more than a single piece of mesh
• • 5. Subject has a surgical wound classified as Class II (clean-contaminated), Class III (contaminated) or Class IV (dirty/infected) as defined by the CDC classification
• • 6. Subject with an American Society of Anesthesiologists (ASA) score of Class 4, 5, or 6
• • 7. Inability to close the hernia defect
• • 8. Subject's procedure required a multi-stage repair
• • 9. Subject's minimally invasive procedure required to convert to open