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

Not Applicable

Recruiting

• Conditions: Ventral Hernia

• Registration Number: NCT06710795
• Lead Sponsor: Medtronic - MITG

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.

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 in the short (1, 3 months) and long term (12 months).

110 male or female subjects will be enrolled in approximately 10 USA sites in subjects who are undergoing elective ventral hernia repair (primary or incisional).

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study Start: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-03-15
• Study Completion: 2027-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of hernia recurrence within 3 months following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.	3-months	The primary endpoint is the incidence of hernia recurrence within 3 months 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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Surgical Site Occurrence (SSO)	Discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months	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.
Incidence of SSO requiring Procedural Intervention (SSOPI)	Discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months	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.
Incidence of hernia recurrence	1-month, 12-months	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.
Incidence of hernia recurrences resulting in reoperation	1-month, 3-months, 12-months	Incidence of hernia recurrences resulting in reoperation, defined as an operative procedure performed with the specific goal of repairing the recurrent hernia.
Incidence of a MaxTack™ Motorized Fixation device deficiency (DD)	Operative Day (Day of Surgery)	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.
Operative time for mesh fixation	Operative Day (Day of Surgery)	Operative time for mesh fixation, defined as the time elapsed from the initiation of the mesh fixation process with MaxTack™ to its completion
Surgeon satisfaction	Operative Day (Day of Surgery)	Surgeon satisfaction as assessed by Surgeon Satisfaction Questionnaire postoperatively.
Length of hospital stay	Discharge (post-surgery up to 1-month)	Length of hospital stay after minimally invasive ventral hernia repair procedure where the MaxTack™ Motorized Fixation Device was used for fixation.
Change in Numeric Rating Scale (NRS) score	Screening compared to 1-month, 3-months, 12-months	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.
Change in Subject Quality of life (QoL)	Screening compared to 1-month, 3-months, 12-months	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.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States