跳至主要内容
临床试验/NCT03718442
NCT03718442Unknown不适用

Low Energy Dissection Vs. Electrocautery Qualitative Severity and Depth of Thermal Artifact in Breast Cancer Lumpectomy Shaved Surgical Margins

Invuity, Inc.0 个研究点目标入组 20 人开始时间: 2019年3月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
Invuity, Inc.
入组人数
20
主要终点
Severity of thermal artifact

研究概览

简要总结

The purpose of this study is to compare the qualitative severity and depth of dissection devices' associated thermal artifact in breast lumpectomy shaved margins between the use of electrocautery and low thermal energy dissection, PhotonBlade.

The investigators hypothesize that the use of PhotonBlade would result in a significantly lower qualitative severity and a shorter depth of thermal artifact in breast lumpectomies shaved margins, when compared to electrocautery devices.

详细描述

When performing lumpectomy, surgeons have used electrocautery devices as dissecting tools. However, those devices use high thermal energy that might impact the margin cellular architecture and as such the quality of margin assessment by the pathologist. Moreover, recently, modern low thermal energy dissection devices have been introduced to the market. However, the impact of those devices on reducing the thermal injury/artifact on surgical margin has not been well investigated. 4,5 While Ruidaz et al. 2011 data suggest that using the traditional electrosurgical device in place of the low thermal-injury device results in 48% of the close margin samples being negatively converted to false-positive, and in 11% converting from close to false-negative, there is still a need for more studies to further characterize the utility of those devices. 6 PhotonBlade (Invuity, San Francisco, CA, USA) has been approved by United States Food and Drug Administration (FDA). PhotonBlade is a dynamic precision illuminator with enhanced energy delivery dissection device. The dynamic precision illumination is a thermally cool illumination technology that allows a uniformal illumination without glare or shadow. 7 The enhanced energy delivery technology allows low thermal spread, surgeon controlled edge temperature, and wet field use.7 As such, PhontonBlade allows better blade control for achieving adequate visualization, hemostasis, with a minimum collateral damage to the surgical margin tissue. The use of PhotonBlade demonstrated the least penetrating thermal tissue damage/spread when compared to other modern dissection devices (Valleylab Pencil, Valleylab EDGE Coated Pencil, PlasmaBlade 3.0S and PlasmaBlade 4.0).8

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

入选标准

  • have aged 18 years old or older.
  • have DCIS or Invasive breast cancer that is eligible for breast-conserving surgery.
  • have not had previous chest radiotherapy.
  • understand the study purpose, requirements, and risks.
  • able and willing to give informed consent.

排除标准

  • 未提供

结局指标

主要结局

Severity of thermal artifact

时间窗: Through study completion, an average of 6 months

The severity of the thermal artifact will be assessed by identifying the presence or absence of each the three qualitative severity zones, described previously,6 as below: * Zone I: extensive charring tissue * Zone II: fused cellular architecture * Zone III: distressed cellular architecture

Depth of thermal artifact

时间窗: Through study completion, an average of 6 months

The depth of the thermal artifact will be assessed by reporting the length in micrometer (μm) from the start of Zone 1 to the end of Zone III.

次要结局

未报告次要终点

研究者

发起方
Invuity, Inc.
申办方类型
Industry
责任方
Sponsor

相似试验