Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
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
- 否
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)
