A prospective, single-arm, open-label, multi-center, observational,post-market clinical follow-up study to evaluate the safety andperformance of i-Tack A sterile absorbable powered mesh fixationdevice in subjects intended for surgical mesh fixation to soft tissue invarious open or laparoscopic surgical procedures.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- 1.Recurrence rate of hernia
研究概览
简要总结
Title: A prospective, single-arm, open-label, multi-center, observational,post-market clinical follow-up study to evaluate the safety andperformance of i-Tack A sterile absorbable powered mesh fixationdevice in subjects intended for surgical mesh fixation to soft tissue invarious open or laparoscopic surgical procedures.
Short Title i-Tack A
Protocol ID, Version& Date: MES/i-Tack A_Version_1.0.0_12-Dec-2024
Study device: i-Tack A (Sterile Absorbable Powered Mesh Fixation Device)
Indication: i-Tack(TM) A is intended for the fixation of surgical mesh to soft tissuein various minimally invasive and open general surgical andlaparoscopic procedures, such as hernia repair.Objective This study aims to evaluate the safety and performance of i-Tack(TM) A.
Study Design: A prospective, single-arm, open-label, multi-center, observational,post-market clinical follow-up study.
Study population: All the consecutive subjects will undergo fixation of surgical mesh tosoft tissue in various minimally invasive and open general surgicaland laparoscopic procedures, such as hernia repair using i-Tack(TM) A
Rationale of the Study: Mesh fixation devices are of fundamental importance in surgical outcomes. Hence, the presentstudy is to evaluate the safety and performance of a sterile absorbable powered mesh fixationdevice composed of the delivery system and i-Tack™ A mesh fixation device in the fixation ofsurgical mesh to soft tissue in various minimally invasive and open general surgical andlaparoscopic procedures, such as hernia repair
.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects who will undergo soft tissue minimally invasive and open general surgical and laparoscopic procedures, such as hernia repair by using i-Tack(TM) A sterile absorbable powered mesh fixation device.
- •Subject will undergo i-Tack(TM) A sterile, absorbable, powered mesh fixation device.
- •Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
- •Subject is not able to write on behalf of the Subject, the Subject`s LAR (Legally acceptable representative) can fill out the informed consent.
- •Adults and elderly Subjects.
- •Subject who willing and able to comply with scheduled postoperative clinical evaluations.
排除标准
- •1.Subjects requiring extended approximation of tissues under stress.
- •Subjects with tissues that have a direct anatomic relationship to major vascular structures.
- •Subjects who underwent ischemic or necrotic tissue surgery.
- •Subjects with tissue that cannot be visually inspected for hemostasis.
- •Subjects with specific drug allergies or past comorbidities.
- •Subjects unfit for general anesthesia.
- •Pregnant women.
结局指标
主要结局
1.Recurrence rate of hernia
时间窗: 1.Time Frame: 7 days ± 2 days, | 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 | months ± 30 days, 12 months ± 30 days | 2. Time Frame: Discharge, 7 days ± 2 days, 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 12 months ± 30 days
2.Adverse Events
时间窗: 1.Time Frame: 7 days ± 2 days, | 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 | months ± 30 days, 12 months ± 30 days | 2. Time Frame: Discharge, 7 days ± 2 days, 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 12 months ± 30 days
3. Complications
时间窗: 1.Time Frame: 7 days ± 2 days, | 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 | months ± 30 days, 12 months ± 30 days | 2. Time Frame: Discharge, 7 days ± 2 days, 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 12 months ± 30 days
次要结局
- 1.Intra-operative complications(2.Re-intervention)