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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Discharge (post-surgery up to 1-month), 1-month, 12-months |
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Preoperative Inclusion Criteria:
Preoperative Exclusion Criteria:
Intraoperative Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haresh Sachanandani | Medtronic (Sponsor) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic - Weston Hospital | Weston | Florida | 33331 | United States | ||
| Cleveland Clinic - Ohio |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All subjects enrolled will receive the MaxTack™ Motorized Fixation Device
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| 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. | Discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months |
| 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. | 1-month, 12-months |
| 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. | 1-month, 3-months, 12-months |
| 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. | Operative Day (Day of Surgery) |
| 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 | Operative Day (Day of Surgery) |
| Surgeon satisfaction | Surgeon satisfaction as assessed by Surgeon Satisfaction Questionnaire postoperatively. | Operative Day (Day of Surgery) |
| 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. | Discharge (post-surgery up to 1-month) |
| 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. | Screening compared to 1-month, 3-months, 12-months |
| 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. | Screening compared to 1-month, 3-months, 12-months |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |