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临床试验/NL-OMON45173
NL-OMON45173招募中3 期

Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique - CBAS5439

COCHLEAR BONE ANCHORED SOLUTIONS AB0 个研究点目标入组 63 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
入组人数
63

研究概览

简要总结

Trial is onging in other countries

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • * Adult patient, i.e. * 18 years of age
  • * Eligible for the Baha system
  • * Signed informed consent

排除标准

  • * Patient scheduled for simultaneously bilateral implant surgery
  • * Uncontrolled diabetes as judged by the investigator
  • * Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
  • * Unable to follow the cleaning instruction
  • * Unable to follow investigational procedures, e.g. to complete quality of life scales
  • * Participation in another investigation with pharmaceuticals and/or device
  • * Condition that may have an impact on the outcome of the investigation as judged by the investigator
  • * Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness

研究者

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