PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

NCT00986453 | Completed Results

• 1 other identifier: PEAK VP-00065
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 7

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).

Conditions

Macromastia

Keywords

Breast Reduction; PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Estimated Blood Loss

  Intraoperative

• Operative Time

  Intraoperative

• Amount of Tissue Removed

  Intraoperative

• Dissection Performance

  Intraoperative

Study Arms (2)

PlasmaBlade arm

EXPERIMENTAL

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

Device: PEAK PlasmaBlade

Standard of Care

ACTIVE COMPARATOR

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

Procedure: Traditional Electrosurgery with scalpel

Interventions

PEAK PlasmaBlade DEVICE

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

Also known as: PlasmaBlade

PlasmaBlade arm

Traditional Electrosurgery with scalpel PROCEDURE

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

Also known as: Scalpel, Electrosurgery, SOC

Standard of Care

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 and 60
• Physically healthy, stable weight, non-smoker
• Desiring bilateral breast reduction
• Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
• Subject must be willing and able to comply with specified follow-up evaluations.
• 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.

You may not qualify if:

• Age younger than 20 or greater than 60 years old
• Anticoagulation therapy which cannot be discontinued
• Smoking (any kind)
• Infection (local or systemic)
• Cognitive impairment or mental illness
• Severe cardiopulmonary deficiencies
• Known coagulopathy
• Immunocompromised
• Prior history of breast cancer
• Kidney disease (any type)
• Currently taking any medication known to affect healing
• Subjects who are status-post gastric banding or gastric bypass
• Currently enrolled in another investigational device or drug trial
• Unable to follow instructions or complete follow-up

Sponsors & Collaborators

• Medtronic Surgical Technologies: lead

Study Sites (7)

Providence St. Joseph's

Burbank, California, 91505, United States

Location

Verdugo Hills Hospital

Glendale, California, 91218, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Tri-City Medical Center

Oceanside, California, 92056, United States

Location

Sharp Outpatient Pavilion

San Diego, California, 92123, United States

Location

Rancho Bernardo Surgery Center

San Diego, California, 92128, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Gigantomastia; Hyperthermia

Interventions

Laser Therapy; Electrosurgery

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Robert Swain, PhD
• Organization: Medtronic Surgical Technologies

robert.e.swain@medtronic.com

+1 (603) 294-5428

Study Officials

• Abhay Gupta, MD

  Gupta Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Howard Rosenberg, MD

  Accent on Aesthetics Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Susan Downey, MD

  Susan Downey, MD, FACS

  PRINCIPAL INVESTIGATOR

• Larry Pollack, MD

  Del Mar Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Hooman Soltanian, MD

  University Hospital Cleveland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2009
• First Posted: September 30, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 1, 2013
• Results First Posted: January 1, 2013

Record last verified: 2012-11

Locations

US (7)