NCT07179419招募中不适用
Evaluation of the Long-term Therapeutic Effect of High-Intensity Focused Ultrasound (HIFU) Treatment in Patients With Rectal Endometriosis
EDAP TMS S.A.1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年10月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Compare the SF36 score assessed before HIFU treatment with that assessed in the long term after HIFU treatment.
研究概览
简要总结
Evaluate the long-term effects of HIFU treatment for rectal endometriosis.
详细描述
This study evaluates the long-term effects of HIFU treatment on endometriosis symptoms in patients who have received this treatment. The patients included will have participated in the following studies: HIFU/F/13.12, ENDO HIFU R1, and ENDO HIFU R2.
Patients will complete an electronic questionnaire and receive a telephone call to monitor these parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have been treated with HIFU for rectal endometriosis included in study HIFU/F/13.12, study HIFU/F/20.01 (ENDO HIFU R1) or study HIFU/F/21.12 (ENDO HIFU R2)
- •Agreeing to participate in the study
- •Patients with internet access so that they can complete the questionnaires electronically.
排除标准
- •Patients deprived of their liberty following a judicial or administrative decision,
- •Patients under guardianship or conservatorship.
结局指标
主要结局
Compare the SF36 score assessed before HIFU treatment with that assessed in the long term after HIFU treatment.
时间窗: every year during 5 years
次要结局
未报告次要终点
研究者
研究点 (1)
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