Evaluation of the Location and the Treatment by High-intensity Focused Ultrasounds (HIFU) of Posterior Deep Infiltrating Endometriosis (DIE) Lesions With Intestinal Involvement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Targeting of the endometriosic lesion
研究概览
简要总结
Deep invasive endometriosis (DIE) includes lesions of the rectosigmoid. Theses lesions are 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 trial is to evaluate the ability of the Focal One® HIFU device to detect and target posterior DIE lesions with intestinal involvement. The secondary objectives are to perform a HIFU lesion, to evaluate morphological modifications of the nodule in post-therapeutic imaging scans, to assess evolution of gynecological symptoms, intestinal symptoms, and patients' quality of life after treatment by HIFU and to collect safety data.
详细描述
20 Subjects with deep invasive endometriosis (DIE) will receive the HIFU treatment with Focal One® device.
Subjects harboring an isolated recto-sigmoid DIE lesion with a persistence of symptoms despite hormonal treatment will be installed on the Focal One® device to:
- Evaluate its ability to locate and assess the volume of the endometriosic lesion
- Treat the targeted lesion by HIFU energy application. Real-time guided ultrasonography will be used to determine the location of the endometriosic nodule. Succession of HIFU exposure will be then used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae to prevent risk of fistulae.
Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and at 1 and 6 months after HIFU procedure. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months.
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
- •Age > 25 years
- •Isolated recto-sigmoid DIE lesion, with no other endometriosis location on imaging examination (intestinal, urinary or ovarian), the persistence of symptoms despite hormonal treatment and therefore consideration for surgical management.
- •Localization of endometriosic lesion described by US, confirmed by MRI
- •Negative urinary pregnancy test and No intention to get pregnant during the following 6 months
- •Affiliated to the French Social Security System
排除标准
- •Hormonal treatment of endometriosis by Luteinizing Hormone Releasing Hormone agonist (LHRH analogs) of less than 3 months
- •Breastfeeding female
- •Uro-genital infection in progress (the infection has to be treated before HIFU treatment)
- •Anatomical abnormality of the rectum
- •Anterior surgery at the level of the anus or rectum
- •Presence of an implant (stent, catheter, contraceptive implant) located less than 1 cm from the treatment area.
- •History of intestinal inflammatory pathology
- •Allergy to latex
- •Female with a medical contraindication on MRI
- •Female with a medical contraindication to Sonovue® injection
- •Female not able to understand the objectives of the study
- •Legal person protected by law
研究组 & 干预措施
HIFU (Focal One®) Treatment
Subjects harboring an isolated recto-sigmoid deep invasive endometriosis (DIE) lesion with a persistence of symptoms despite hormonal treatment will be installed on the Focal One® device to:
- Evaluate its ability to locate and assess the volume of the endometriosic lesion
- Treat the targeted lesion by HIFU energy application. Real-time guided ultrasonography will be used to determine the location of the endometriosic nodule.
Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and 1 and 6 months after HIFU. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months.
干预措施: HIFU (Focal One®) (Device)
结局指标
主要结局
Targeting of the endometriosic lesion
时间窗: Day 1
The main criterion of evaluation will lie on the targeting of the Endometriosic lesion with the Focal One® probe. Measure of the volume of the Endometriosic lesion to treat: targeted volume (estimation from the measures of the length, the height and the width of the nodule).
次要结局
- Medical Outcome assessment (Study Short Form-36)(6 months)
- Urinary symptom profile assessment(6 months)
- Anatomical position of the Focal One probe(Day 1)
- Safety of the procedure: assessment of complications during the procedure attributable to the technique(Day 1)
- Assessment of Adverse Events during the 6 months follow-up attributable to the technique(6 months)
- Sexual function assessment(6 months)
- Effect of HIFU treatment on endometriosic lesion(Day 1)
- endometriosis health profile assessment(6 months)
- Constipation assessment(6 months)
- Anal continence assessment(6 months)