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临床试验/EUCTR2021-006904-34-FR
EUCTR2021-006904-34-FR进行中(未招募)1 期

Evaluation of the interest of perianal infiltration during thermodestruction of haemorrhoidal disease by Radiofrequency (RAFAELO® procedure) - RAFAELOCA

Centre Hospitalier Départemental Vendée0 个研究点目标入组 134 人开始时间: 2022年4月29日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
134

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Major patient
  • - Patient scheduled to undergo hemorrhoidal thermodestruction surgery (RAFAELO® procedure)
  • - Patient able to understand the protocol and having given written informed consent to participate in the study
  • - Patient affiliated to the social security system or entitled to it
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 34

排除标准

  • - Patient < 18 years old
  • - Patient with previous hemorrhoidectomy surgery (LONGO technique)
  • - Patient with previous pexy ligation surgery (HAL-RAR technique)
  • - Patients with known hypersensitivity to local anaesthetics or components
  • - Patient with a long term (>1 month) analgesic treatment (level II and III)
  • - Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
  • - Patient who is pregnant, breastfeeding or able to procreate without contraception
  • - Patient under guardianship, curatorship or deprived of liberty

研究者

发起方
Centre Hospitalier Départemental Vendée

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