Breast Cancer
Conditions
Keywords
Lumpectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
Brief summary
The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality metrics; to examine the role that electrosurgical artifact may play in revision lumpectomy procedures; and to compare these endpoints to the standard of care (SOC) technology.
Detailed description
Lumpectomy is a surgical procedure performed to remove a localized mass of breast tissue that is suspicious for malignancy. The purpose of lumpectomy is to minimize the amount of tissue removed from the breast to retain normal breast architecture while simultaneously removing all of the suspected cancerous tissue. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any cancerous tissue. The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the pathological analysis of excised breast lumps. This single site study was granted Institutional Review Board (IRB) approval and conducted between June 2009 and January 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were then required to provide informed consent prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PEAK PlasmaBlade study groups and scheduled for lumpectomy.
Interventions
DEVICEPEAK PlasmaBlade
The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade including the skin incision
The skin incision will be performed using a standard scalpel; the subcutaneous dissection will be performed with traditional electrosurgery using the Cut and Coagulation modes.
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 90 years old 2. Physically healthy, stable weight 3. Requiring lumpectomy with wire localization for suspected or confirmed malignant breast disease. 4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure. 5. Subject must be willing and able to comply with all follow-up evaluations
Exclusion criteria
1. Age younger than 18 or greater than 90 years old 2. Infection (local or systemic) 3. Cognitive impairment or mental illness 4. Severe cardiopulmonary deficiencies 5. Unable to follow instructions or complete follow-up 6. Currently taking any medication known to affect healing 7. Currently enrolled in another investigational device or drug trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen | Intraoperative | Overall histological quality score will be a composite of the histological metrics |
Secondary
| Measure | Time frame |
|---|---|
| Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring | Intraoperatively and 1-2 weeks postoperatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PlasmaBlade The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision. | 25 |
| Standard of Care (SOC) The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study termination | 25 | 25 |
Baseline characteristics
| Characteristic | PlasmaBlade | Standard of Care (SOC) | Total |
|---|---|---|---|
| Age, Customized 18 to 90 years | 25 participants | 25 participants | 50 participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 1 / 25 | 0 / 25 |
Outcome results
Primary
Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen
Overall histological quality score will be a composite of the histological metrics
Time frame: Intraoperative
Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.
Secondary
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring
Time frame: Intraoperatively and 1-2 weeks postoperatively
Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.