Evaluating a new device for fixing hernias during surgery
AFFIX: Evaluation of the performAnce and saFety of the MaxTack™ Motorized FIXation Device in Subjects Undergoing Repair of Ventral Hernia by Minimally Invasive Surgery
This study is testing a new device called the MaxTack™ to see if it safely helps fix hernias during minimally invasive surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic - MITG Industry-sponsored |
| Locations | 3 sites (Weston, Florida and 2 other locations) |
| Trial ID | NCT06710795 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the MaxTack™ Motorized Fixation Device for its safety and performance in minimally invasive ventral hernia repair procedures. It is a prospective, post-market, multicenter, nonrandomized, single-arm interventional study sponsored by Medtronic. Participants will be monitored for short-term (1 and 3 months) and long-term (12 months) outcomes. The study aims to enroll up to 110 subjects across multiple sites in the United States.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing elective, minimally invasive ventral hernia repair using the MaxTack™ device and Medtronic mesh.
Not a fit: Patients requiring emergency surgery or those with complex medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of ventral hernia repair surgeries.
How similar studies have performed: Other studies have shown promise with similar fixation devices, but this specific approach is being evaluated in a post-market setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Weston, Florida and 2 other locations
- Cleveland Clinic - Weston Hospital — Weston, Florida, United States (Recruiting)
- Cleveland Clinic - Ohio — Cleveland, Ohio, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Alyssa Sutch, M.S.
- Email: alyssa.m.sutch@medtronic.com
- Phone: 612-214-9756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.