跳至主要内容
临床试验/NCT04171102
NCT04171102已完成不适用

Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor

University of Cagliari0 个研究点目标入组 15 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
主要终点
Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor

研究概览

简要总结

The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.

详细描述

Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
  • Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
  • Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor

排除标准

  • Patients who underwent inguinal hernia repair with conventional flat meshes

结局指标

主要结局

Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor

时间窗: 3 weeks until 8 months post-implantation

Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Amato

Consultant Professor

University of Cagliari

相似试验