AFFIX: Evaluation of the performAnce and saFety of the MaxTack™ Motorized FIXation Device in Subjects Undergoing Repair of Ventral Hernia by Minimally Invasive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All subjects enrolled will receive the MaxTack™ Motorized Fixation Device
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative Inclusion Criteria:
- •Subject has provided informed consent (IC)
- •Subject is 18 years of age or older at the time of consent
- •Subject is able and willing to comply with the study requirements and follow-up schedule
- •Subject is undergoing an elective, single-stage, primary or incisional ventral hernia repair
- •Subject is undergoing minimally invasive ventral hernia repair procedure using the MaxTack™ Motorized Fixation Device
- •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)
- •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
排除标准
- •Subject is undergoing an emergency surgery (e.g., lifesaving procedures performed where subject is in imminent danger of death, strangulated hernia, etc.)
- •Subject has history of 3 or more hernia repair procedures
- •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
- •Subject is scheduled (or anticipated to be scheduled) for additional surgery, and subsequent surgery would jeopardize previous application of study treatment
- •Subject has history of allergic reactions to Poly (Glycolide-co-L-lActide) (PGLA)
- •Subject has history of allergic reactions to the components of the intended mesh
- •Subject has any systemic or local ongoing infection at the time of the surgery
- •Subject has a Body Mass Index (BMI) greater than 45 kg/m2
- •Subject has life expectancy in the opinion of the investigator, of less than 3 years at the time of enrollment
- •Subject is pregnant (as determined by standard site practices) or is planning to become pregnant during study duration period.
- •Subject has participated or will participate in an investigational drug or device research study that would interfere with the results of this study
- •Subject's participation in the study may jeopardize the safety or welfare of the subject, as determined by the investigator
- •Subject is already enrolled or was previously enrolled in this study
- •Intraoperative Exclusion Criteria:
- •Subject did not receive the MaxTack™ Motorized Fixation Device tacks to fixate the mesh
- •Subject did not receive a Medtronic (including Covidien) mesh
- •Inability to comply with the mesh IFU
- •Subject required more than a single piece of mesh
- •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
- •Subject with an American Society of Anesthesiologists (ASA) score of Class 4, 5, or 6
- •Inability to close the hernia defect
- •Subject's procedure required a multi-stage repair
- •Subject's minimally invasive procedure required to convert to open
研究组 & 干预措施
MaxTack™ Motorized Fixation Device
Subjects treated with MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair
干预措施: MaxTack™ Motorized Fixation Device (Device)
结局指标
主要结局
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.
时间窗: 3-months
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.
Incidence of hernia recurrence within 3 months following the MaxTack™ Motorized Fixation Device used for fixation in minimally invasive ventral hernia repair procedures.
时间窗: 3-months
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.
次要结局
- Incidence of Surgical Site Occurrence (SSO)(Discharge (post-surgery up to 1-month), 1-month, 12-months)
- Incidence of SSO requiring Procedural Intervention (SSOPI)(Discharge (post-surgery up to 1-month), 1-month, 3-months, 12-months)
- Incidence of hernia recurrence(1-month, 12-months)
- Incidence of hernia recurrences resulting in reoperation(1-month, 3-months, 12-months)
- Incidence of a MaxTack™ Motorized Fixation device deficiency (DD)(Operative Day (Day of Surgery))
- Operative time for mesh fixation(Operative Day (Day of Surgery))
- Surgeon satisfaction(Operative Day (Day of Surgery))
- Length of hospital stay(Discharge (post-surgery up to 1-month))
- Change in Numeric Rating Scale (NRS) score(Screening compared to 1-month, 3-months, 12-months)
- Change in Subject Quality of life (QoL)(Screening compared to 1-month, 3-months, 12-months)