BiRF-C Tissue Ablation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ablation depth
研究概览
简要总结
Study of ablation depth using new bipolar electrode prototype design (BiRF-C) utilizing Radio Frequency technology in excised human cervix tissue, discarded during routine clinical care
BiRF-C is a product in research and development. The indication for the product when developed will be cervical dysplasia. In the proposed study the device prototype will be used for testing tissue ablation depth in discarded fresh (<5 hours) cervical tissue specimen at different power settings configurations
This study intends to assess the feasibility of a new technology, BiRF-C ablation prototype for cervical tissue ablation. Results will provide inputs to further modify the prototype design and identify the optimum power, ablation duration, form factor and electrical design in the future version(s) of the prototype.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •20-60 years of age Patients undergoing total or radical hysterectomy due to non-malignant disease, during routine clinical care.
- •The subject or her Legally Authorized Representative (LAR) has been informed about the nature of the study and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements Study team able to test discarded excised tissues within 5 hours after hysterectomy.
排除标准
- •Malignancy/cancerous tissue in the uterus Not willing to consent.
结局指标
主要结局
Ablation depth
时间窗: Within five hours of hysterectomy performed as per routine clinical care
次要结局
- Not applicable(Not applicable)