AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Her… (NCT06710795) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
AFFIX: Post-market Study of MaxTackâ„¢ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
United States35 participantsStarted 2025-06-16
Plain-language 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 MaxTackâ„¢ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Incidence of Surgical Site Occurrence (SSO) within 3 months following the MaxTackâ„¢ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.
Timeframe: 3-months
2
Incidence of hernia recurrence within 3 months following the MaxTackâ„¢ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.