PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

NCT ID: NCT00960154

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-02-29

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PlasmaBlade

The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Group Type: EXPERIMENTAL

PEAK PlasmaBlade

Intervention Type: DEVICE

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

SOC

The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.

Group Type: ACTIVE_COMPARATOR

Traditional Electrosurgery with scalpel

Intervention Type: PROCEDURE

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.

Interventions

PEAK PlasmaBlade

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

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

PlasmaBlade; Scalpel; Electrosurgery; SOC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Surgical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Naruns, MD

Role: PRINCIPAL_INVESTIGATOR

Midpeninsula Surgical Associates

Khoi Tran, MD

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Locations

El Camino Surgery Center

Mountain View, California, United States

Palo Alto Medical Foundation

Mountain View, California, United States

Countries

United States

Other Identifiers

PEAK VP-00078

Identifier Type: -

Identifier Source: org_study_id