AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tissium
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Hernia Recurrence at 6 months
研究概览
简要总结
The primary purpose of this clinical trial is to assess the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. The study will evaluate whether ECLIPSIUM, a bioresorbable polymer-based fixation device, is effective in reducing the risk of hernia recurrence when compared with bioresorbable tacks. This information will support understanding of ECLIPSIUM's potential clinical benefits in ventral hernia repair.
详细描述
A prospective, multi-center, randomized, active control, single-blind non- inferiority study designed to evaluate the safety and effectiveness of the ECLIPSIUM® System versus bioresorbable tacks in mesh fixation in patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 22 years old or older.
- •Patient is willing and able to provide a signed Patient Informed Consent Form.
- •Patient has a single midline primary ventral, umbilical, or incisional hernia;
- •a.Hernia Size is 1 -5 cm in diameter (to be confirmed intraoperatively).
- •Patient is scheduled for a laparoscopic IPOM hernia repair.
- •Hernia can be successfully repaired with a single polyester or polypropylene composite mesh with biodegradable coating with at least a 5 cm overlap of the mesh on all sides of the defect (to be confirmed intraoperatively).
- •Female patients must:
- •Have a negative urine pregnancy test within 3 days before surgery and agree to consistently use an effective method of contraception through completion of study participation.
- •Have reached menopause (no menses for 1 year). OR
- •Have undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
- •Patient is willing and able to follow the study instructions including completion of study procedures, assessments, and visits.
排除标准
- •Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, comparator device, mesh, or other surgical products (e.g., sutures).
- •Patient is taking systemic photosensitivity pharmaceutical products at time of informed consent.
- •Patient has a BMI >
- •Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day.
- •Patient's hernia is recurrent and/or the patient has a previous midline primary ventral, umbilical, or incisional hernia repair with mesh implantation.
- •Patient has a life expectancy less than 1 year, in the opinion of the Investigator.
- •Patient is unwilling or unable to follow postoperative instructions.
- •Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent.
- •Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding.
- •Patient has a diagnosis of Type 1 Diabetes Mellitus.
- •Patient has uncontrolled Type 2 Diabetes Mellitus (HbA1C ≥ 7.0 within 3 months preceding study enrolment).
- •Patient is currently participating in an investigational drug or device study that has not completed the primary outcome or that clinically interferes with this clinical study's outcome (Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational studies).
- •Patient has more than one hernia defect (single hernia defect between 1-5 cm in diameter from outer edged to outer edge to be confirmed intraoperatively).
- •Patient has areas of weakness, independent from the hernia to be treated, in the area covered by mesh or mesh-adjacent tissues (to be confirmed intraoperatively).
- •Patient with a complex hernia, likely not eligible for laparoscopic repair, as determined by the Investigator (ex. small bowel resection; to be confirmed intraoperatively).
- •Patient is scheduled for an additional surgery within 6 weeks after the index-procedure or has undergone surgery within 90 days before the index-procedure.
- •Patient has severe chronic obstructive pulmonary disease.
- •Patient has an ongoing infection (e.g. elevated temperature, elevated white blood count).
- •In the opinion of the Investigator, the patient is not a suitable candidate for the clinical investigation.
研究组 & 干预措施
ECLIPSIUM System
The ECLIPSIUM System is intended for non-penetrating connection and fastening of prosthetic materials, such as composite meshes, to internal soft tissue during minimally invasive hernia repair procedures by coating the prosthetic material with the biodegradable implantable polymer and photoactivating it in situ with a TISSIUM curing light.
干预措施: ECLIPSIUM® System (Device)
Resorbable tacks (AbsorbaTack/SorbaFix)
Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function.
干预措施: Resorbable tacks (AbsorbaTack/SorbaFix) (Device)
结局指标
主要结局
Hernia Recurrence at 6 months
时间窗: 6 months
Rate of hernia recurrence of the ECLIPSIUM System compared to resorbable tacks at 6 months post-surgery.
Cumulative Incidence of Complications
时间窗: 12 months
Safety of the ECLIPSIUM System will be assessed by collecting and analyzing the cumulative incidence of complications (CIC) related to the ECLIPSIUM System including the following complications: * Infection * Chronic pain (defined as moderate or greater pain lasting more than 3 months) not otherwise specified * Impaired/delayed healing at the surgical site (i.e. hernia repair site; example dehiscence) * Allergic reaction/hypersensitivity reaction to the constituent polymer of the investigational device * Serious Adverse Device Effect (SADEs)
次要结局
- Hernia Recurrence at 12 months(12 months)