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A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBladeTM 4.0 in Breast Lumpectomy


N/A
18 Years
90 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBladeTM 4.0 in Breast Lumpectomy


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen

Outcome Description:

Overall histological quality score will be a composite of the histological metrics

Outcome Time Frame:

Intraoperative

Safety Issue:

No

Principal Investigator

Peter Naruns, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Midpeninsula Surgical Associates

Authority:

United States: Institutional Review Board

Study ID:

PEAK VP-00078

NCT ID:

NCT00960154

Start Date:

July 2009

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • Lumpectomy
  • PlasmaBlade
  • Electrosurgery
  • PEAK Surgical
  • Medtronic Advanced Energy
  • Medtronic
  • Breast Neoplasms

Name

Location
Palo Alto Medical Foundation Palo Alto, California  94301
El Camino Surgery Center Mountain View, California  94040