AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
AFFIX: Evaluation of the performAnce and saFety of the MaxTack™ Motorized FIXation Device in Subjects Undergoing Repair of Ventral Hernia by Minimally Invasive Surgery
Medtronic - MITG
110 participants
Nov 26, 2024
INTERVENTIONAL
Conditions
Summary
Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study. The purpose of this study is to evaluate the performance and safety of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures.
Eligibility
Inclusion Criteria7
- Subject has provided informed consent (IC)
- Subject is 18 years of age or older at the time of consent
- Subject is able and willing to comply with the study requirements and follow-up schedule
- Subject is undergoing an elective, single-stage, primary or incisional ventral hernia repair
- Subject is undergoing minimally invasive ventral hernia repair procedure using the MaxTack™ Motorized Fixation Device
- 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)
- Subject is expected to meet the criteria for a class I wound (clean) as defined by Centers for Disease Control and Prevention (CDC) classification
Exclusion Criteria22
- Subject is undergoing an emergency surgery (e.g., lifesaving procedures performed where subject is in imminent danger of death, strangulated hernia, etc.)
- Subject has history of 3 or more hernia repair procedures
- 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
- Subject is scheduled (or anticipated to be scheduled) for additional surgery, and subsequent surgery would jeopardize previous application of study treatment
- Subject has history of allergic reactions to Poly (Glycolide-co-L-lActide) (PGLA)
- Subject has history of allergic reactions to the components of the intended mesh
- Subject has any systemic or local ongoing infection at the time of the surgery
- Subject has a Body Mass Index (BMI) greater than 45 kg/m2
- Subject has life expectancy in the opinion of the investigator, of less than 3 years at the time of enrollment
- Subject is pregnant (as determined by standard site practices) or is planning to become pregnant during study duration period.
- Subject has participated or will participate in an investigational drug or device research study that would interfere with the results of this study
- Subject's participation in the study may jeopardize the safety or welfare of the subject, as determined by the investigator
- Subject is already enrolled or was previously enrolled in this study
- Subject did not receive the MaxTack™ Motorized Fixation Device tacks to fixate the mesh
- Subject did not receive a Medtronic (including Covidien) mesh
- Inability to comply with the mesh IFU
- Subject required more than a single piece of mesh
- 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
- Subject with an American Society of Anesthesiologists (ASA) score of Class 4, 5, or 6
- Inability to close the hernia defect
- Subject's procedure required a multi-stage repair
- Subject's minimally invasive procedure required to convert to open
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Interventions
All subjects enrolled will receive the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06710795