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临床试验/NCT02137018
NCT02137018Unknown1 期

"Nanotechnologies Applied to General Surgery and Emergency Surgery: The Buckypaper as a New Fixing Method for Prosthetic Materials in the Treatment of Abdominal Wall Hernias, Diaphragmatic Hernias, Diaphragmatic Rupture, Incisional Hernia and Abdominal Wall Disaster in Laparotomy Procedure and Laparoscopic Procedures".

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
30
试验地点
2
主要终点
Time of durability without side effects of surgical device

研究概览

简要总结

"Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic procedures". Experimentation on breed pig Lantrace ANIMAL MODEL.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 6 Months(Child)
性别
Female
接受健康志愿者

入选标准

  • animal model: lantrace female pigs of 20 kg of body weight

排除标准

  • any kind of illness in porcine subjects

结局指标

主要结局

Time of durability without side effects of surgical device

时间窗: up to 36 months

We are testing the time (months/year) of durability without side effects of a new fixing method for prosthetic materials for abdominal wall hernias and wall defects repairing on pig model

次要结局

  • time required to position the device during surgery(up to 36 months)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Chiaretti

Researcher

University of Roma La Sapienza

研究点 (2)

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