PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy (PRECISE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Device: PEAK PlasmaBlade; Procedure: Traditional Electrosurgery with scalpel

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • Palo Alto Medical Foundation
    • Mountain View, California, United States, 94040
      • El Camino Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PlasmaBlade; The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.	Device: PEAK PlasmaBlade; The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade including the skin incision; Other Names: PlasmaBlade
Active Comparator: SOC; The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.	Procedure: Traditional Electrosurgery with scalpel; 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.; Other Names: SOC; Electrosurgery; Scalpel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring	Intraoperatively and 1-2 weeks postoperatively

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies
• Investigators: Principal Investigator: Peter Naruns, MD, Midpeninsula Surgical Associates; Principal Investigator: Khoi Tran, MD, Palo Alto Medical Foundation

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 13, 2009
• First Submitted That Met QC Criteria: August 14, 2009
• First Posted (Estimate): August 17, 2009

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic; Lumpectomy
• Other Study ID Numbers: PEAK VP-00078