PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

Breast Cancer Clinical Trial

— PRECISE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00960154
• Other study ID #: PEAK VP-00078
• Status: Terminated
• Phase: N/A
• First received: August 13, 2009
• Last updated: January 3, 2013
• Start date: July 2009
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• PEAK PlasmaBlade
The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade including the skin incision

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.

Locations

Country	Name	City	State
United States	El Camino Surgery Center	Mountain View	California
United States	Palo Alto Medical Foundation	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Intraoperative	No
Secondary	Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring		Intraoperatively and 1-2 weeks postoperatively	No