NCT02011919已完成不适用
Treatment of Breast Fibroadenoma 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
- 27
- 试验地点
- 1
- 主要终点
- FA volume changes from baseline
研究概览
简要总结
This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device
Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One 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
- 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 with at least one diagnosed breast fibroadenoma.
- •Diagnosis of fibroadenoma must be based on:
- •clinical examination,
- •women ≤ 40 years of age: ultrasound image alone; women > 40 years of age: ultrasound image and mammogram,
- •histological confirmation of fibroadenoma of the breast.
- •Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm.
- •Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment.
- •Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures.
- •Patient must give written informed consent (personally signed and dated) before completing any study-related procedure.
排除标准
- •Patient who is pregnant or breast-feeding.
- •Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion.
- •Patient with implant on the treated breast.
- •Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU.
- •Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
- •Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.
研究组 & 干预措施
Echopulse
Other
Echopulse HIFU
干预措施: Echopulse (Device)
结局指标
主要结局
FA volume changes from baseline
时间窗: Every year during 5 years
次要结局
- Palpability(Every year during 5 years)
- Pain assessment(Every year during 5 years)
- Duration of the treatment session(Every year during 5 years)
- Cosmetic result(Every year during 5 years)
- Gland vascularisation(Every year during 5 years)
- Histological outcome(Every year during 5 years)
- Energy settings(Every year during 5 years)
- Breast immobilization(Every year during 5 years)
- Ease of implementation of treatment(Every year during 5 years)
研究者
研究点 (1)
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