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Procedure

MaxTack™ Device for Hernia Repair (AFFIX Trial)

N/A

Recruiting

Research Sponsored by Medtronic - MITG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is undergoing an elective, single-stage, primary or incisional ventral hernia repair

Subject is 18 years of age or older at the time of consent

Must not have

Subject is undergoing an emergency surgery

Subject has history of 3 or more hernia repair procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess the effectiveness and safety of the MaxTack™ Motorized Fixation Device in attaching prosthetic material to soft tissue during minimally invasive ventral hernia repair surgeries. Med

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, potential risks may include pain at the fixation site, infection, bleeding, hernia recurrence, or complications related to the use of any surgical device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a first-time or repeat ventral hernia repair surgery.

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I am 18 years old or older.

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I am having a hernia repair with the MaxTack™ device.

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I am having a hernia repair with Medtronic mesh as per the usage instructions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having an emergency surgery.

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I have had 3 or more hernia repair surgeries.

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I already have a mesh where a new one needs to be placed using MaxTack™.

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I do not have any ongoing infections at the time of surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in Numeric Rating Scale (NRS) score

Change in Subject Quality of life (QoL)

Incidence of SSO requiring Procedural Intervention (SSOPI)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 8Eligibility criteria met