MaxTack™ Device for Hernia Repair
(AFFIX Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic - MITG
Disqualifiers: Emergency surgery, 3+ hernia repairs, Existing mesh, Allergic reactions, Infections, BMI > 45, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Eligibility 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
+4 more
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
+10 more
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: MaxTack™ Motorized Fixation DeviceExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State UniversityColumbus, OH
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Who Is Running the Clinical Trial?
Medtronic - MITGLead Sponsor
References
Pros and cons of tacking in laparoscopic hernia repair. [2019]Present available fixation devices in laparoscopic hernia repair include transfascial sutures, (permanent or absorbable) tacks, and fibrin or synthetic sealants, all of which have advantages and disadvantages. Tack fixation has been applied since the introduction of laparoscopic inguinal and ventral hernia repair during the end of the 1980s and the beginning of the 1990s, respectively. However, although this type of penetrating fixation offers a reliable method to keep the mesh in place, several negative aspects have been highlighted in recent years. Permanent metallic fixation devices such as helical titanium tacks (Protack™ ) provide greater fixation strength than absorbable fixation devices (AbsorbaTack™, Permasorb™, or SorbaFix™), but as the titanium tacks remain in the body permanently, they have been associated with serious adverse events. Dense adhesion formation and erosion of tacks in hollow viscera have been reported as well as the formation of so-called "tack hernias." However, the most clinically important negative aspect might be the increased acute and chronic postoperative pain. As pain and quality of life, rather than recurrence rate, gained the attention of clinicians, researchers, and patients, recent developments have been focusing on different types of absorbable materials. However, studies that investigated these issues comparing different tack materials for mesh fixation did not show any benefit from any type of fixation. Despite the postoperative short- and long-term sequellae, tack fixation is still the most widely applied technique for laparoscopic mesh fixation.
Possible applications of the "Manuflex" external fixing instrument in small animal surgery. [2005]An external fixing instrument (minifixateur externe) recently developed for use in humans and marketed by the name of "MANUFLEX", its accessories, possible applications and fields of indication are described. The apparatus has been patented in Hungary and an international patent has been applied for. In the second part of the paper the application of the external fixateur for treating bone fractures of dogs is reported, together with the practical experience gained with it so far. As the clinical trials gave favourable results and since the instrument is available for veterinary practitioners at a reasonable price, MANUFLEX may become a gap-filling apparatus in the instrumentarium of small animal surgery.
Reuse of external fixation components: a randomized trial. [2022]External fixation devices are sold in the United States as single-use devices and can be costly. Approved processes for refurbishment of nonimplantable components are available. We evaluated one such program for safety, efficacy, and fiscal ramifications.
Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength. [2021]Laparoscopic ventral hernia repair is commonly performed with mesh prostheses; however, there is no standard for fixation devices used to secure mesh to the abdominal wall. This study is a functional comparison of novel, screw-type absorbable and permanent fixation devices with a traditional titanium fixation device.
Sliding performance of unilateral external fixators for tibia. [2019]Some unilateral external fixators have a sliding mechanism to achieve dynamic axial fixation. However, it has been reported that binding of this mechanism occurs during routine ambulation. The Hifixator, a unilateral external fixator, has been developed which has a new type of sliding mechanism. The mechanism of the Hifixator was tested by connecting it to a fractured bone model with pins, and applying dynamic axial loading. The conditions of connection between the pins and bone model were varied to simulate loosening of the pins. Two other external fixators commonly used for tibias, Orthofix and Monotube (blue), were tested for comparison. The amount of sliding motion of the Hifixator was maintained at more than 72% of the motion at the fracture site even when pins were loose and a torque of 4 N m was applied. The sliding mechanism of the Hifixator was shown to be more durable than those of the other fixators tested for conditions found in application to tibias.