Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

NCT01404351 | Withdrawn

• 1 other identifier: VP-00133
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 to compare these outcomes to the HARMONIC SYNERGY® BLADE.

Conditions

Macromastia (Symptomatic)

Keywords

Reduction mammaplasty; Breast reduction; PlasmaBlade; PEAK

Outcome Measures

Primary Outcomes (1)

• Difference in pain

  The primary endpoint will be the difference in pain between the Harmonic and PlasmaBlade operative sites. The primary efficacy variable will be pain at each treatment arm operative site, as measured by visual analog scale for 24 hours post-operatively and for 10 post-op days twice daily.

  24 hours and first 10 days post-op

Secondary Outcomes (3)

• Operative performance

  Intraoperatively on day 0

• Adverse events

  1 month post-operatively

• Cutaneous scarring

  Up to one year post-operatively

Study Arms (2)

PEAK PlasmaBlade

EXPERIMENTAL

Device: PEAK PlasmaBlade

Standard of Care

ACTIVE COMPARATOR

The Standard of Care arm will consist of the scalpel for the skin incision and traditional electrosurgery for subcutaneous dissection.

Procedure: Scalpel and Traditional Electrosurgery

Interventions

PEAK PlasmaBlade DEVICE

PEAK PlasmaBlade

Scalpel and Traditional Electrosurgery PROCEDURE

Standard of Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70
• Physically healthy, stable weight
• No smoking \<1 month prior to surgery and during study.
• 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 incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study.

You may not qualify if:

• Age younger than 18 or greater than 70 years old
• Anticoagulation therapy which cannot be discontinued
• Smoking \<1 month prior to surgery or during study
• 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 (1)

Gonyon Cosmetic & Plastic Surgery, PC

Johnstown, Colorado, 80534, United States

Location

MeSH Terms

Conditions

Gigantomastia

Study Officials

• Denis Gonyon, MD

  Gonyon Cosmetic & Plastic Surgery, PC

  PRINCIPAL INVESTIGATOR

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: July 25, 2011
• First Posted: July 28, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

US (1)