Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins

Brief Summary
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.
Brief Title
Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins
Detailed Description
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
Central Contacts
Central Contact Role
Contact
Central Contact Phone
6502486662
Central Contact Email
ddalma@invuity.com
Central Contact Role
Contact
Central Contact Phone
415-846-9105
Central Contact Email
jkang@invuity.com
Completion Date
Completion Date Type
Estimated
Conditions
Breast Cancer Female
Eligibility Criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* None
Inclusion Criteria
Inclusion Criteria:

* 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.

Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03718442
Org Class
Industry
Org Full Name
Invuity, Inc.
Org Study Id
2018-8984
Overall Status
Unknown status
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Low Energy Dissection Vs. Electrocautery Qualitative Severity and Depth of Thermal Artifact in Breast Cancer Lumpectomy Shaved Surgical Margins
Primary Outcomes
Outcome Description
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
Outcome Measure
Severity of thermal artifact
Outcome Time Frame
Through study completion, an average of 6 months
Outcome Description
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.
Outcome Measure
Depth of thermal artifact
Outcome Time Frame
Through study completion, an average of 6 months
Start Date
Start Date Type
Estimated
Status Verified Date
First Submit Date
First Submit QC Date
Study Population
Women who have a diagnosis of breast cancer and undergo a lumpectomy
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sheldon Feldman
Investigator Email
sfeldman@montefiore.org
Investigator Phone