AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
NCT06710795 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-08-11
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.
Conditions
- Ventral Hernia
Interventions
- DEVICE
-
MaxTack™ Motorized Fixation Device
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
Sponsors & Collaborators
-
Medtronic - MITG
lead INDUSTRY
Principal Investigators
-
Eric Vang · Medtronic (Sponsor)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-16
- Primary Completion
- 2026-07-28
- Completion
- 2027-05-07
- FDA Device
- Yes
Countries
- United States
Study Locations
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