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
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