Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 12
- 主要终点
- Objective success
研究概览
简要总结
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
详细描述
LatGYNious is a preformed mesh implant which combines two types of polypropylene meshes with different properties. The mesh body is made of ultra-light monofilament polypropylene with a wide hexagonal pore structure with a high level of elasticity. A reinforced mesh material with a smaller pore structure is used for the mesh arms, which achieves a strong lateral fixation. The overlap area of the two mesh types is designed to combine the properties of both structures. In case of a uterus preserving approach, the posterior part of the mesh body is removed.
The aim of the present study is to generate clinical data to show the safety and performance of LatGYNious for the treatment of female pelvic organ prolapse.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic prolapse in one of the 3 compartments from grade 2 with or without uterus
- •Subject is candidate for a surgical treatment of pelvic organ prolapse
- •Subject is willing and able to cooperate with follow-up examinations
- •Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.
排除标准
- •Previous surgical treatment with a mesh implant for pelvic organ prolapse (mesh implant in anterior or posterior compartment)
- •Active immunotherapy which may negatively affect the treatment with a surgical mesh
- •Active cancer of the vagina / cervix / rectum
- •. known or suspected hypersensitivity to Polypropylene
- •Pregnancy
- •participation in another study at the same time
- •Unable to understand study requirements or is unable to comply with follow-up schedule
- •Contraindicated according to the instruction for use of the device
研究组 & 干预措施
Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)
干预措施: Laparoscopic lateral suspension with surgical mesh (LatGYNious) (Device)
结局指标
主要结局
Objective success
时间窗: During follow-up until 6 and 12 months after surgery
The primary objective is to confirm the effectiveness and objective success rate (anatomical correction defined by POP-Q) of a laparoscopic lateral mesh implant. Objective success is determined by anatomical measurement (POP-Q) pre- and post-operatively. Objective cure is defined as: * POP-Q values Ba, C and Bp \< -1 (according to Barber et al.). * Absence of pelvic floor prolapse/bulge symptoms based on questionnaire (P-QoL). * No additional POP treatment necessary
Objective success
时间窗: During follow-up until 6 and 12 months after surgery
The primary objective is to confirm the effectiveness and objective success rate (anatomical correction defined by POP-Q) of a laparoscopic lateral mesh implant. Objective success is determined by anatomical measurement (POP-Q) pre- and post-operatively. Objective cure is defined as: * POP-Q values Ba, C and Bp \< -1 (according to Barber et al.). * Absence of pelvic floor prolapse/bulge symptoms based on questionnaire (P-QoL). * No additional POP treatment necessary
次要结局
- Quality of Life (QoL)(During follow-up until 6 and 12 months after surgery)
- Subjective success(During follow-up until 6 and 12 months after surgery)
- Complications(From operation during follow-up until 6 and 12 months after surgery.)
- Quality of Life (QoL)(During follow-up until 6 and 12 months after surgery)
- Subjective success(During follow-up until 6 and 12 months after surgery)