Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
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.
In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient 18 years of age or older,
- •Rectal endometriosis on preoperative imaging with no other digestive location,
- •Symptomatic patient (Acute pelvic pain > 3), in failure of drug treatment,
- •Endometriotic lesion visible on ultrasound and confirmed on MRI,
- •Centralized MRI, reviewed and validated by the MRI review committee,
- •No current pregnancy and no pregnancy plan during the study period,
- •Patient agreeing not to change her hormonal treatment throughout the study period,
- •Patient accepting the constraints of follow-up defined in the framework of the study,
- •Patient affiliated to French health insurance.
排除标准
- •Ongoing urogenital infection,
- •Anorectal anatomy incompatible with HIFU treatment,
- •Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
- •History of segmental rectal resection or discoid resection,
- •Patient with an implant located less than 1 cm from the treatment area,
- •Inflammatory disease of the colon,
- •Allergy to latex,
- •No scheduled endometriosis procedures during study follow-up,
- •Treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate
- •Patient with contraindications to MRI,
- •Patient who has already received HIFU treatment for a rectal endometriotic lesion,
- •Patient who does not speak or read French,
- •Patient deprived of liberty following a judicial or administrative decision,
- •Patient in labor or nursing,
- •Patient under guardianship or curatorship
结局指标
主要结局
Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
时间窗: 3 months
The efficacy of HIFU treatment will be assessed by comparing the evolution in the level of acute pelvic pain assessed by Visual Analog Scale (VAS), ranging from 0 (best situation) to 10 (worst situation) at 3 months, to the pre-treatment pain level. The evolution in the HIFU group will be compared to those in the sham intervention group.
次要结局
- Overall recovery time evaluation(3 months)
- Evaluation of sexual fonction(1 and 3 months)
- Post treatment medication rate(10 days)
- Post treatment pain rate(10 days)
- Adverse Events occurrence and comparison between the two groups(3 months)
- Evaluation of constipation(1 and 3 months)
- Quality of life evoluation(1 and 3 months)
- Evaluation of anal continence(1 and 3 months)
- Evaluation of urinary symptoms(1 and 3 months)
- Symptoms evolution evaluation(1 and 3 months)
- Volume lesion evaluation(3 months)