An observational study in Breast Cancer Female, sponsored by Invuity, Inc.. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-24.
Sponsored by Invuity, Inc. · Observational
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.
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 20 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Invuity, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Women who have a diagnosis of breast cancer and undergo a lumpectomy
Exclusion Criteria:
Women who are 18 years or older, have Ductal carcinoma in situ (DCIS) or invasive breast-conserving surgery, have not had previous chest radiotherapy. 20 patients who meet above study population criteria will be enrolled in this study.Shaved margins for each lumpectomy site will be excised with either Bovie (3 sides) or PhotonBlade (3 sides) for each patient. The effect of PhotonBlade vs Bovie on pathology assessment of lumpectomy shaved surgical margins will be compared.
Device: PhotonBlade vs Bovie for lumpectomy shaved surgical margins
For each enrolled patient, six shaved margins will be obtained (superior, inferior, medial, lateral, anterior, and posterior). For each patient, electrocautery will be used to obtain 3 of the shaved margins, and PhotonBlade to obtain the other 3 shaved margins. Once the lumpectomy site shaved margins have been obtained, the shaved surgical margins will be evaluated by a pathologist whom is blinded in regards to the dissection device that was used for each margin. The pathologist will be evaluating each shaved margin and reporting the outcomes (qualitative severity and depth of thermal artifact)
Severity of thermal artifact
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
Time frame: Through study completion, an average of 6 months
Depth of thermal artifact
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.
Time frame: Through study completion, an average of 6 months
No study locations are listed for this record.
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Invuity, Inc.