PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

NCT ID: NCT00986453

Last Updated: 2013-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-09-30

Brief Summary

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).

Detailed Description

Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue from both female breasts for therapeutic or cosmetic indications. The purpose of the breast reduction is to decrease the weight of the breasts and restructure the breast tissue for a more favorable appearance. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any excess 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 post-operative outcome of patients undergoing bilateral breast reduction.

A total of forty-five (45) subjects were enrolled into the study. Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery. Enrollment and surgeries took place between 18 September 2009 and 12 August 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent prior to enrollment. Following enrollment, subject operative sites were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for bilateral breast reduction. Subjects were unaware of which device was used on which breast. Subjects were required to attend two follow-up visits after surgery, approximately one and six weeks following surgery.

Conditions

Macromastia

Study Design

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

Study Groups

PlasmaBlade arm

The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.

Group Type: EXPERIMENTAL

PEAK PlasmaBlade

Intervention Type: DEVICE

The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.

Standard of Care

Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Group Type: ACTIVE_COMPARATOR

Traditional Electrosurgery with scalpel

Intervention Type: PROCEDURE

Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Interventions

PEAK PlasmaBlade

The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.

Intervention Type: DEVICE

Traditional Electrosurgery with scalpel

Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Intervention Type: PROCEDURE

Other Intervention Names

PlasmaBlade; Scalpel; Electrosurgery; SOC

Eligibility Criteria

Inclusion Criteria

1. Age between 20 and 60

2. Physically healthy, stable weight, non-smoker

3. Desiring bilateral breast reduction

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 specified follow-up evaluations.

6. Female subjects must either be no longer capable of reproduction, or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.

Exclusion Criteria

1. Age younger than 20 or greater than 60 years old

2. Anticoagulation therapy which cannot be discontinued

3. Smoking (any kind)

4. Infection (local or systemic)

5. Cognitive impairment or mental illness

6. Severe cardiopulmonary deficiencies

7. Known coagulopathy

8. Immunocompromised

9. Prior history of breast cancer

10. Kidney disease (any type)

11. Currently taking any medication known to affect healing

12. Subjects who are status-post gastric banding or gastric bypass

13. Currently enrolled in another investigational device or drug trial

14. Unable to follow instructions or complete follow-up

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic Surgical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abhay Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Gupta Plastic Surgery

Howard Rosenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Accent on Aesthetics Plastic Surgery

Susan Downey, MD

Role: PRINCIPAL_INVESTIGATOR

Susan Downey, MD, FACS

Larry Pollack, MD

Role: PRINCIPAL_INVESTIGATOR

Del Mar Plastic Surgery

Hooman Soltanian, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Cleveland

Locations

Providence St. Joseph's

Burbank, California, United States

Verdugo Hills Hospital

Glendale, California, United States

El Camino Hospital

Mountain View, California, United States

Tri-City Medical Center

Oceanside, California, United States

Sharp Outpatient Pavilion

San Diego, California, United States

Rancho Bernardo Surgery Center

San Diego, California, United States

University Hospitals

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

PEAK VP-00065

Identifier Type: -

Identifier Source: org_study_id