American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- To help refine, improve and/or validate breast tumor best practices and standard of care
研究概览
简要总结
The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.
详细描述
ABLATE is a prospective, observational multi-center tracking database which will evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosis confirmed by needle core biopsy
- •Tumors detected either by physical exam or imaging
- •Tumors do not exceed 2 cm in diameter and measure at least 0.5 cm away from the skin and chest wall
- •Single, multiple and/or bilateral tumors
- •Patient has given consent prior to being treated with Novilase™
排除标准
- •Patient is pregnant or lactating
- •Hypercellularity suggestive of phyllodes
- •Equivocal pathology report (e.g., discordance between radiographic and microscopic results)
- •Fibroadenomas with stromal solidarity
结局指标
主要结局
To help refine, improve and/or validate breast tumor best practices and standard of care
时间窗: ongoing
To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols
时间窗: ongoing
To monitor and measure long term safety and effectiveness Novilase
时间窗: ongoing
To support the medical and patient communities through transparency--by contributing and publishing relevant, useful and meaningful data to support the development and design of future research
时间窗: ongoing
次要结局
未报告次要终点