RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-26

Study Completion:2027-02-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06710795

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Alyssa Sutch, M.S.

CONTACT

612-214-9756

alyssa.m.sutch@medtronic.com

Marion Blanc, PharmD

CONTACT

+33 4 74 09 90 00

marion.blanc@medtronic.com

Principal Investigator

Elodie Franchimont

STUDY_DIRECTOR

Medtronic/Sponsor

Study Locations (Sites)

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Medtronic - MITG

Elodie Franchimont, STUDY_DIRECTOR, Medtronic/Sponsor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26

Study Completion Date2027-02-15

Study Record Updates

Study Start Date2024-11-26

Study Completion Date2027-02-15

Terms related to this study

Additional Relevant MeSH Terms

Ventral Hernia