NCT04494568已完成不适用
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
EDAP TMS S.A.6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Evaluate the tolerance of rectal endometriosis treatment with HIFU
研究概览
简要总结
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.
The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged at least 25 years-old
- •Rectal endometriosis in preoperative imaging, without other digestive locations (colon, ileum and small intentine)
- •Symptomatic patient refusing hormonal treatment and/or surgery.
- •Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium MRI and difusion sequence (according to standardized protocol)
- •Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the probe in front of the rectal nodule)
- •Distance from the upper pole to the anal margin ≤ 15 cm (measurement by MRI with intra-rectal contrast)
- •No curent pregnancy (negative BHCG <72h before the HIFU procedure) and no pregnancy project within 6 months after the HIFU procedure (post-treatment MRI delay)
- •Patient agreeing not to change her hormone treatment for the duration of the study.
- •Patient accepting the study constraints
- •Health insurance affiliated patient or beneficiary of an equivalent coverage
排除标准
- •Virgin patient
- •Ongoing uro-genital infection
- •Anorectal anatomy incompatible with HIFU therapy
- •History of segmental rectal resection with mechanical anastomosis, shaving or discoid resection
- •Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE® contraceptive implants).
- •Inflammatory colon disease (ulcerative colitis, Crohn's disease and others)
- •Latex allergy
- •Patient with contraindications to MRI
- •Patient with contraindications to Gadolinium injection
- •Patient previously treated with HIFU for a rectal endometriotic lesion
- •Patient not speaking nor reading French
- •Patient deprived of liberty following a legal or administrative decision
- •Patient under guardianship or tutelage measure
结局指标
主要结局
Evaluate the tolerance of rectal endometriosis treatment with HIFU
时间窗: 6 months
The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
次要结局
- Evaluation of the of quality of life evolution of patients after HIFU treatment(at 1 month, 3 months and 6 months post-intervention,)
- Evaluation of the evolution of the nodule's volume(at 6 months)
- Evaluation of the post-intervention analgesic treatment(during the fisrt 10 days post treatment.)
- Evaluation of the sexual symptoms evolution of patients after HIFU treatment(at 1 month, 3 months and 6 months post-intervention)
- Evaluation of the gynecological symptoms evolution of patients after HIFU treatment(at 1 month, 3 months and 6 months post-intervention)
- Evaluation of the urinary symptoms evolution of patients after HIFU treatment(at 1 month, 3 months and 6 months post-intervention)
- Evaluation of the digestive symptoms evolution of patients after HIFU treatment(at 1 month, 3 months and 6 months post-intervention)
研究者
研究点 (6)
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