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

NCT06710795 | Active Not Recruiting FDA Device

• 1 other identifier: MDT23014
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Surgical Site Occurrence (SSO) within 3 months following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.

  The Phase 1 primary endpoint is the incidence of Surgical Site Occurrence (SSO) within 3 months following the use of the MaxTack™ Motorized Fixation Device for fixation in ventral hernia repair procedures. SSOs are considered Adverse Events (AEs) related to the study device, mesh, and/or study procedure and defined as Seroma, Hematoma, Surgical Site Infection (SSI), and bleeding at the tack implantation site. Note: Non-symptomatic seromas requiring no medical or surgical treatment are not reportable AEs. All symptomatic seromas as well as non-symptomatic seromas that require treatment, are considered reportable AEs.

  3-months

• Incidence of hernia recurrence within 3 months following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.

  The Phase 2 primary endpoint is the incidence of hernia recurrence within 3 months following the use of MaxTack™ Motorized Fixation Device for fixation in minimally invasive ventral hernia repair procedures. Hernia recurrence is defined as a palpable fascial defect and/or a clinically manifested bulge, exacerbated by a Valsalva maneuver evaluated during a physical examination by the investigator and confirmed per site standard of care medical imaging, if necessary, at the respective clinical site. If a Valsalva maneuver is not conducted during physical examination, this must be reported as a protocol deviation. If standard of care imaging is done for hernia recurrence confirmation, the final decision to report a hernia recurrence will be based on the study investigator's assessment. Standard of care imaging may be done by a non-study, standard of care assessor, such as a radiologist.

  3-months

Secondary Outcomes (10)

• Incidence of Surgical Site Occurrence (SSO)

  Discharge (post-surgery up to 1-month), 1-month, 12-months

• Incidence of SSO requiring Procedural Intervention (SSOPI)

  Discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months

• Incidence of hernia recurrence

  1-month, 12-months

• Incidence of hernia recurrences resulting in reoperation

  1-month, 3-months, 12-months

• Incidence of a MaxTack™ Motorized Fixation device deficiency (DD)

  Operative Day (Day of Surgery)

Study Arms (1)

MaxTack™ Motorized Fixation Device

EXPERIMENTAL

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

Device: MaxTack™ Motorized Fixation Device

Interventions

MaxTack™ Motorized Fixation Device DEVICE

All subjects enrolled will receive the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair

MaxTack™ Motorized Fixation Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent (IC)
• Subject is 18 years of age or older at the time of consent
• Subject is able and willing to comply with the study requirements and follow-up schedule
• Subject is undergoing an elective, single-stage, primary or incisional ventral hernia repair
• Subject is undergoing minimally invasive ventral hernia repair procedure using the MaxTack™ Motorized Fixation Device
• 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)
• Subject is expected to meet the criteria for a class I wound (clean) as defined by Centers for Disease Control and Prevention (CDC) classification

You may not qualify if:

• Subject is undergoing an emergency surgery (e.g., lifesaving procedures performed where subject is in imminent danger of death, strangulated hernia, etc.)
• Subject has history of 3 or more hernia repair procedures
• 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
• Subject is scheduled (or anticipated to be scheduled) for additional surgery, and subsequent surgery would jeopardize previous application of study treatment
• Subject has history of allergic reactions to Poly (Glycolide-co-L-lActide) (PGLA)
• Subject has history of allergic reactions to the components of the intended mesh
• Subject has any systemic or local ongoing infection at the time of the surgery
• 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 (as determined by standard site practices) or is planning to become pregnant during study duration period.
• Subject has participated or will participate in an investigational drug or device research study that would interfere with the results of this study
• Subject's participation in the study may jeopardize the safety or welfare of the subject, as determined by the investigator
• Subject is already enrolled or was previously enrolled in this study
• Subject did not receive the MaxTack™ Motorized Fixation Device tacks to fixate the mesh
• Subject did not receive a Medtronic (including Covidien) mesh

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (3)

Cleveland Clinic - Weston Hospital

Weston, Florida, 33331, United States

Location

Cleveland Clinic - Ohio

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Haresh Sachanandani

  Medtronic (Sponsor)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All subjects enrolled will receive the MaxTack™ Motorized Fixation Device
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 29, 2024
• Study Start: June 16, 2025
• Primary Completion: March 23, 2026
• Study Completion (Estimated): May 7, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)