A Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Healing Process assessed by BREAST-Q Questionnaire
研究概览
简要总结
This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy in patients undergoing breast conserving surgery for breast cancer. Radiofrequency ablation, or RFA, uses radio waves to create heat, that in turn, causes deliberate controlled damage to the tissue surrounding where the tumor was located. You may hear your doctor refer to this as the 'margins'. Your doctor is using this treatment to help destroy remaining cancer cells in the margins around the site of the lump.
详细描述
During your surgery, after your lump is removed, the surgeon will place the SIRA-1000 in the breast cavity and perform the RF ablation procedure to treat the margins of the lumpectomy surgical site. A stitch will be used to stabilize and secure the tissue around the neck of the SIRA-1000 to ensure that contact is maintained between the SIRA-1000 electrode array and cavity tissue.
Upon completion of the RF ablation treatment, your tumor and the tissue samples from the ablated edges of the surgical site will be sent for review under a microscope (pathology).
After this, your surgery will be completed as standard, and your discharge will be determined by your medical team like any other surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biologic female
- •50 years of age and older
- •Confirmed diagnosis of breast cancer:
- •Infiltrating ductal carcinoma
- •ER/PR+Her2neu-
- •Grade I, II, or III
- •Unicentric, unilateral tumor size ≤ 3cm
- •Tumor location ≥ 2 cm from skin and other structures
- •Zubrod Performance Status of 0, 1, or 2
- •No palpable lymphadenopathy
- •Able and willing to provide written informed consent
排除标准
- •Pregnant or breastfeeding
- •Neoadjuvant chemotherapy
- •Cardiac arrhythmia
- •Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device
- •Current or history of breast implants
- •Multi-centric or bilateral breast cancer
- •Diffuse microcalcifications
- •Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study
- •Has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
研究组 & 干预措施
Feasibility and safety study for women undergoing BCS.
RFA electrosurgical device as an adjunct to BCS.
干预措施: Radiofrequency ablation alone (Device)
Feasibility and safety study for women undergoing BCS.
RFA electrosurgical device as an adjunct to BCS.
干预措施: Radiofrequency ablation Electrosurgical Device (Device)
结局指标
主要结局
Healing Process assessed by BREAST-Q Questionnaire
时间窗: 6 months
Assess healing process using cosmesis and quality of life patient reported outcomes.
To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events.
时间窗: The study will span a total of approximately 12 months with a follow-up for 5 years.
Assess the occurrence adverse events and to evaluate the impact of RFA on healing process.
次要结局
未报告次要终点