MaxTack™ Device for Hernia Repair

(AFFIX Trial)

Recruiting at 2 trial locations

Overseen By Marion Blanc, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic - MITG

Disqualifiers: Emergency surgery, 3+ hernia repairs, Existing mesh, Allergic reactions, Infections, BMI > 45, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: Operative Day

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team or your doctor for guidance.

How is the MaxTack™ Motorized Fixation Device treatment different from other hernia repair treatments?

The MaxTack™ Motorized Fixation Device is unique because it offers a motorized approach to securing mesh during hernia repair, potentially reducing the manual effort required compared to traditional tacking methods. This could lead to more consistent fixation and possibly less postoperative pain, addressing some of the drawbacks associated with permanent metallic tacks. ^{1 2 3 4 5}

Research Team

Haresh Sachanandani

Principal Investigator

Medtronic (Sponsor)

Eligibility Criteria

This trial is for individuals who need surgery to repair a ventral hernia, which is a bulge of tissues through an opening within abdominal muscles. Participants should be suitable candidates for minimally invasive surgical procedures.

Inclusion Criteria

Subject has provided informed consent

Subject is able and willing to comply with the study requirements and follow-up schedule

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 has a Body Mass Index (BMI) greater than 45 kg/m2

Subject has life expectancy in the opinion of the investigator, of less than 3 years at the time of enrollment

Subject is pregnant or is planning to become pregnant during study duration period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Subjects treated with MaxTack™ Motorized Fixation Device for fixation of prosthetic material in minimally invasive ventral hernia repair

Operative Day

1 visit (in-person)

Short-term Follow-up

Participants are monitored for hernia recurrence and device performance within 1 to 3 months post-surgery

3 months

2-3 visits (in-person)

Long-term Follow-up

Participants are monitored for hernia recurrence and quality of life changes up to 12 months post-surgery

12 months

3-4 visits (in-person)

Treatment Details

Interventions

• MaxTack™ Motorized Fixation Device

Trial Overview The AFFIX study tests the MaxTack™ Motorized Fixation Device's performance and safety in securing mesh material during minimally invasive ventral hernia repair surgeries. This device aims to improve outcomes by enhancing mesh fixation.

Participant Groups

Group I: MaxTack™ Motorized Fixation Device Experimental Treatment 1 Intervention

Subjects treated with MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair

MaxTack™ Motorized Fixation Device is already approved in United States for the following indications:

Approved in United States as MaxTack™ Motorized Fixation Device for:

• Fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures
• Fixation of prosthetic material to soft tissue in minimally invasive groin hernia repair procedures

Who Is Running the Clinical Trial?

Medtronic - MITG

Lead Sponsor

Trials

265

Recruited

301,000+

Geoff Martha

Medtronic - MITG

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. John Doe

Medtronic - MITG

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

Tack fixation, while providing strong mesh support in laparoscopic hernia repair, has been linked to serious complications such as chronic pain, adhesion formation, and erosion, particularly with permanent metallic tacks like titanium.

Despite the drawbacks and the emergence of absorbable materials, tack fixation remains the most commonly used method for mesh fixation in laparoscopic procedures, as studies have not demonstrated a clear advantage of alternative fixation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pros and cons of tacking in laparoscopic hernia repair. Reynvoet, E., Berrevoet, F.[2019]

The MANUFLEX external fixing instrument has been developed for human use and is now being applied successfully in veterinary medicine, particularly for treating bone fractures in dogs, showing promising clinical trial results.

This device is not only patented in Hungary but is also available at a reasonable price for veterinary practitioners, potentially filling a significant need in small animal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible applications of the "Manuflex" external fixing instrument in small animal surgery. Cziffer, E., Tóth, J.[2005]

A randomized clinical trial involving 96 patients showed that refurbished external fixation components are as safe and effective as new components, with no significant differences in complications like pin tract infections or loss of fixation.

The refurbishment program resulted in a cost savings of $65,452, which is about 25% of the total cost of using new frames, highlighting its fiscal benefits in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reuse of external fixation components: a randomized trial. Sung, JK., Levin, R., Siegel, J., et al.[2022]

In a study involving 15 pigs, screw-type absorbable and permanent fixation devices for mesh in laparoscopic ventral hernia repair resulted in significantly less tenacious adhesions compared to traditional titanium fixation devices, indicating a potential safety advantage.

The titanium spiral tacks provided the highest pull-off force, suggesting strong fixation, but the absorbable and permanent screw-type devices still offered adequate fixation while reducing adhesion formation, which is important for patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength. Byrd, JF., Agee, N., Swan, RZ., et al.[2021]

The Hifixator, a new unilateral external fixator, demonstrated superior durability in its sliding mechanism, maintaining over 72% of motion at the fracture site even when pins were loosened during dynamic axial loading.

In comparison to other common external fixators like Orthofix and Monotube, the Hifixator's design reduces the risk of binding during ambulation, potentially improving patient outcomes in tibia fracture treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sliding performance of unilateral external fixators for tibia. Matsushita, T., Nakamura, K., Ohnishi, I., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pros and cons of tacking in laparoscopic hernia repair. [2019]

2. Hungary pubmed.ncbi.nlm.nih.gov

Possible applications of the "Manuflex" external fixing instrument in small animal surgery. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

Reuse of external fixation components: a randomized trial. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Sliding performance of unilateral external fixators for tibia. [2019]