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Ventral HerniaAFFIXNCT06710795

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

A study testing MaxTack™ Motorized Fixation Device in people with Ventral Hernia, run by Medtronic - MITG at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventral Hernia
What is being tested?
MaxTack™ Motorized Fixation Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesUnited States
Study dates
16 Jun 2025to 7 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Cleveland Clinic - Ohio

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Cleveland Clinic - Weston Hospital

    Weston, Florida, 33331

Other trials in United States

About this study

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

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.

Read the detailed description

A prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures. Subjects will be followed in the short term (1 and 3 months) and long term (12 months) to evaluate safety and performance of the device.

The study is being conducted in two phases. Phase 1 will enroll approximately 33 subjects at up to 3 sites in the United States. Based on regulatory needs, Phase 2 may enroll additional subjects at approximately 10 US sites, for a total of up to 110 subjects across both phases.

Conditions
Ventral Hernia
Being tested
MaxTack™ Motorized Fixation Device
Medical subject headings
Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaxTack™ Motorized Fixation DeviceDevice

    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

Study groups in NCT06710795
Study groupRoleWhat they receive
MaxTack™ Motorized Fixation DeviceExperimentalSubjects treated with MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair
Receives: Device: MaxTack™ Motorized Fixation Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3-months

  2. 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.

    Measured: 3-months

Secondary outcomes (10)

  1. Incidence of Surgical Site Occurrence (SSO)

    Incidence of Surgical Site Occurrence (SSO) which are the following AEs related to the study device, mesh, and / or study procedure and defined as seroma, hematoma, surgical site infection, bleeding at tack implantation site following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.

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

  2. Incidence of SSO requiring Procedural Intervention (SSOPI)

    Incidence of SSO requiring Procedural Intervention (SSOPI) which are the following AEs related to the study device, mesh, and / or study procedure (seroma, hematoma, surgical site infection, bleeding at tack implantation site) following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.

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

  3. Incidence of hernia recurrence

    Incidence of hernia recurrence following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures. Hernia recurrence is defined as a palpable fascial defect and/or 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.

    Measured: 1-month, 12-months

  4. Incidence of hernia recurrences resulting in reoperation

    Incidence of hernia recurrences resulting in reoperation, defined as an operative procedure performed with the specific goal of repairing the recurrent hernia.

    Measured: 1-month, 3-months, 12-months

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

    Incidence of MaxTack™ Motorized Fixation Device deficiencies (e.g., insufficient tack penetration, loose tacks, tack(s) migration, tacker issue battery etc.) on day of the index procedure.

    Measured: Operative Day (Day of Surgery)

  6. Operative time for mesh fixation

    Operative time for mesh fixation, defined as the time elapsed from the initiation of the mesh fixation process with MaxTack™ to its completion

    Measured: Operative Day (Day of Surgery)

  7. Surgeon satisfaction

    Surgeon satisfaction as assessed by Surgeon Satisfaction Questionnaire postoperatively.

    Measured: Operative Day (Day of Surgery)

  8. Length of hospital stay

    Length of hospital stay after minimally invasive ventral hernia repair procedure where the MaxTack™ Motorized Fixation Device was used for fixation.

    Measured: Discharge (post-surgery up to 1-month)

  9. Change in Numeric Rating Scale (NRS) score

    Change in subject-reported pain at the hernia site evaluated with Numeric Rating Scale (NRS) score from 0 to 10 at screening and compared to other timepoints. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.

    Measured: Screening compared to 1-month, 3-months, 12-months

  10. Change in Subject Quality of life (QoL)

    Change in Subject Quality of life (QoL), as measured through the administration of the Hernia Quality of Life (HerQLes) questionnaire, evaluated at screening and compared to other timepoints. This is reported as a score from 0-100 with higher numbers indicating better quality of life.

    Measured: Screening compared to 1-month, 3-months, 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start16 Jun 2025
  3. Primary completion28 Jul 2026
  4. Study completion7 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06710795
Sponsor's protocol ID
MDT23014
Acronym
AFFIX
Status last verified
Aug 2026
First submitted
22 Nov 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MaxTack™ Motorized Fixation Device in people with Ventral Hernia, run by Medtronic - MITG at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06710795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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