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

Description

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

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Study Overview

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Study Details

Study 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.

AFFIX: Evaluation of the performAnce and saFety of the MaxTack™ Motorized FIXation Device in Subjects Undergoing Repair of Ventral Hernia by Minimally Invasive Surgery

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

Condition
Ventral Hernia
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic - MITG,

Elodie Franchimont, STUDY_DIRECTOR, Medtronic/Sponsor

Study Record Dates

2027-02-15