跳至主要内容
临床试验/NCT00396617
NCT00396617Unknown1 期

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2007年12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
14
试验地点
2
主要终点
Clinical measures concerning peri and intra prosthetic leakage

研究概览

简要总结

The benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. The functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • age more than 18
  • total laryngectomy or pharyngo-larynctomy

排除标准

  • pregnant women-age less than 18
  • major pulmonary bronchitis
  • major neurological disorders

结局指标

主要结局

Clinical measures concerning peri and intra prosthetic leakage

时间窗: days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36

次要结局

  • Phonology's measures(months 1, 3,12)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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