NCT03044054已完成不适用
Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 113
- 试验地点
- 4
- 主要终点
- Anxiety level assessment
研究概览
简要总结
This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.
详细描述
Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
- •Diagnosis of fibroadenoma must be based on:
- •Clinical examination
- •Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or
- •BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance.
- •Histologic confirmation by core needle biopsy.
- •Patient is a candidate for the surgery.
- •The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.
- •The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.
- •The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU treatment must also be at least 3 mm from any border of the fibroadenoma.
- •Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in volume (measured by ultrasound on the day of the procedure).
- •Fibroadenoma is palpable.
- •Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
- •Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
- •Patient has signed a written informed consent.
排除标准
- •Patient is pregnant or nursing.
- •Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women > 35 years old, the diagnostic mammogram should be evaluated for calcification. In women ≤ 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded based on the findings of calcification on a single view mammogram.
- •Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
- •Patient with breast implants in the target breast.
- •Patient with a breast cyst within the fibroadenoma to be treated.
- •Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
- •Patient participating in another clinical trial involving an investigational drug, device or biologic.
研究组 & 干预措施
ECHOPULSE
Experimental
ECHOPULSE HIFU
干预措施: ECHOPULSE (Device)
结局指标
主要结局
Anxiety level assessment
时间窗: 12 Months
visual analog scale
Volume assessment
时间窗: 12 Months
Ultrasound measurement
Pain level assessment
时间窗: 12 Months
visual analog scale
次要结局
- The short (6-item) version of the State-Trait Anxiety Inventory (STAI)(inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months)
- Palpability of the breast fibroadenoma(inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months)
- Freedom from additional procedures for fibroadenoma of the breast(Day 2/3, Day 7, 6 months, 12 months)
- Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial.(Day 0, Day 2/3, Day 7, 6 months, 12 months)
- Patient satisfaction(Month 6 and Months 12)
研究者
研究点 (4)
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