Clinical trial NCT06710795: AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2024-11-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 3-months
measure: Incidence of hernia recurrence within 3 months following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.
timeFrame: 3-months
Secondary outcomes:
measure: Incidence of Surgical Site Occurrence (SSO)
timeFrame: Discharge (post-surgery up to 1-month), 1-month, 12-months
measure: Incidence of SSO requiring Procedural Intervention (SSOPI)
timeFrame: Discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months
measure: Incidence of hernia recurrence
timeFrame: 1-month, 12-months
measure: Incidence of hernia recurrences resulting in reoperation
timeFrame: 1-month, 3-months, 12-months
measure: Incidence of a MaxTack™ Motorized Fixation device deficiency (DD)
timeFrame: Operative Day (Day of Surgery)
measure: Operative time for mesh fixation
timeFrame: Operative Day (Day of Surgery)
measure: Surgeon satisfaction
timeFrame: Operative Day (Day of Surgery)
measure: Length of hospital stay
timeFrame: Discharge (post-surgery up to 1-month)
measure: Change in Numeric Rating Scale (NRS) score
timeFrame: Screening compared to 1-month, 3-months, 12-months
measure: Change in Subject Quality of life (QoL)
timeFrame: Screening compared to 1-month, 3-months, 12-months
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic - Weston Hospital
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic - Ohio
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Medtronic (Sponsor)
name: Haresh Sachanandani
role: STUDY_DIRECTOR
References: