PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Macromastia Clinical Trial

— PRECISE  

Official title:

A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986453
• Other study ID #: PEAK VP-00065
• Status: Completed
• Phase: N/A
• First received: September 28, 2009
• Last updated: November 29, 2012
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2012
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Macromastia

Intervention

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

Procedure:
• Traditional Electrosurgery with scalpel
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Locations

Country	Name	City	State
United States	Providence St. Joseph's	Burbank	California
United States	University Hospitals	Cleveland	Ohio
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	Rancho Bernardo Surgery Center	San Diego	California
United States	Sharp Outpatient Pavilion	San Diego	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	Postoperative Pain	The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites.; Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.	0 to 10 days postoperative	No
Secondary	Estimated Blood Loss		Intraoperative	No
Secondary	Operative Time		Intraoperative	No
Secondary	Amount of Tissue Removed		Intraoperative	No
Secondary	Dissection Performance	Amount of tissue (g) removed over time (min)	Intraoperative	No