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

N/AActive Not RecruitingNCT06710795

Medtronic - MITG35 enrolled

Overview

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.

A prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures. Subjects will be followed in the short term (1 and 3 months) and long term (12 months) to evaluate safety and performance of the device. The study is being conducted in two phases. Phase 1 will enroll approximately 33 subjects at up to 3 sites in the United States. Based on regulatory needs, Phase 2 may enroll additional subjects at approximately 10 US sites, for a total of up to 110 subjects across both phases.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventral Hernia

Interventions

MaxTack™ Motorized Fixation DeviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Cleveland Clinic - Weston Hospital

Weston, Florida, United States

Cleveland Clinic - Ohio

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Incidence of Surgical Site Occurrence (SSO) within 3 months following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.

The Phase 1 primary endpoint is the incidence of Surgical Site Occurrence (SSO) within 3 months following the use of the MaxTack™ Motorized Fixation Device for fixation in ventral hernia repair procedures. SSOs are considered Adverse Events (AEs) related to the study device, mesh, and/or study procedure and defined as Seroma, Hematoma, Surgical Site Infection (SSI), and bleeding at the tack implantation site. Note: Non-symptomatic seromas requiring no medical or surgical treatment are not reportable AEs. All symptomatic seromas as well as non-symptomatic seromas that require treatment, are considered reportable AEs.

Time frame: 3-months

Incidence of hernia recurrence within 3 months following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.

The Phase 2 primary endpoint is the incidence of hernia recurrence within 3 months following the use of MaxTack™ Motorized Fixation Device for fixation in minimally invasive ventral hernia repair procedures. Hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge, exacerbated by a Valsalva maneuver evaluated during a physical examination by the investigator and confirmed per site standard of care medical imaging, if necessary, at the respective clinical site. If a Valsalva maneuver is not conducted during physical examination, this must be reported as a protocol deviation. If standard of care imaging is done for hernia recurrence confirmation, the final decision to report a hernia recurrence will be based on the study investigator's assessment. Standard of care imaging may be done by a non-study, standard of care assessor, such as a radiologist.

Time frame: 3-months

Secondary Outcomes

Incidence of Surgical Site Occurrence (SSO)

Incidence of Surgical Site Occurrence (SSO) which are the following AEs related to the study device, mesh, and / or study procedure and defined as seroma, hematoma, surgical site infection, bleeding at tack implantation site following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.

Data from ClinicalTrials.gov

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