PMCF Study to Evaluate the Safety and Performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 109
- 试验地点
- 3
- 主要终点
- Effectiveness of the LiquiBand FIX8 OHMF device
研究概览
简要总结
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to understand and give informed consent to take part in the study
- •Subject has a primary inguinal hernia.
- •Subject is scheduled to undergo open inguinal hernia repair using the LiquiBand FIX8® OHMF device.
- •Subject is willing and able to comply with the protocol assessments at time of surgery and during the post-surgical follow-up period.
排除标准
- •Subject is undergoing open repair surgery for recurrent hernia, where the primary surgery was also open. Subjects with recurrent hernia whose primary surgery was laparoscopic are not excluded.
- •Subject has an anatomical defect or had prior surgical procedures that in the opinion of the investigator makes them unsuitable for open hernia repair with the LiquiBand FIX8® OHMF device.
- •Subject is known to be non-compliant with medical treatment.
- •Subject is pregnant or actively breastfeeding.
- •Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study.
- •Subject has a known sensitivity to cyanoacrylate or formaldehyde, D&C Violet No.2 dye or any other component of LiquiBand FIX8® OHMF device.
- •The hernia mesh to be used in the repair is constructed from Polytetrafluoroethylene (PTFE) or absorbable materials.
- •The hernia mesh to be used in the repair is a self-gripping mesh (e.g. ProGrip).
- •Subject has active or potential infection at the surgical site.
- •Subject has a history of keloid formation.
- •Subject has a known vitamin C or zinc deficiency.
- •Subject has a connective tissue disorder.
研究组 & 干预措施
LiquiBand FIX8® OHMF Device
Subjects will undergo hernia mesh fixation and topical wound closure using the LiquiBand FIX8® OHMF device.
干预措施: LiquiBand FIX8 Open Hernia Mesh Fixation Device (Device)
结局指标
主要结局
Effectiveness of the LiquiBand FIX8 OHMF device
时间窗: Time of surgery
Effectiveness will be defined as successful fixation of the hernia mesh (ie not requiring additional fixation by an alternate device) using the LiquiBand FIX8 device at the time of surgery. Based on data pooled from published studies of a similar device (which employs the same cyanoacrylate glue to fix hernia mesh, via a laparoscopic rather than open surgical approach), there has been an observed failure rate of 0.8% in mesh fixation. This study aims to demonstrate non-inferiority of the LiquiBand FIX8 device to a failure rate of 5% (medically acceptable inference).
次要结局
- Comparison of costs of patients' clinical events treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.(12-months)
- Comparison of cost-effectiveness of patients treated with the LiquiBand FIX8 OHMF device compared with costs for those treated using standard surgical technique.(12-months)
- Clinician satisfaction(0 (Post Surgery) and upto 2 days (hospital discharge))
- Effectiveness of the LiquiBandFIX8 OHMF device for topical wound closure(Time of surgery)
- Safety of the LiquiBand FIX8 OHMF device(0 (intra-operatively), up to 2 days (discharge from hospital) and 12-months post surgery)
- Assessment of chronic post-operative pain using the Visual Analogue Scale: the minimal clinically important difference and patient acceptable symptom state.(12-months post-surgery)
- Long term performance of the study device(12-months post surgery)