Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT06710795
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06710795
Study Brief:
Protocol Section:
NCT06710795