ClinicalTrials.gg
Sign In
WithdrawnNCT01404351Updated Jan 7, 2013

Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

An interventional study of PEAK PlasmaBlade and Scalpel and Traditional Electrosurgery in Macromastia (Symptomatic), sponsored by Medtronic Surgical Technologies. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-07.

Sponsored by Medtronic Surgical Technologies (part of Medtronic) · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Study terminated due to the acquisition of PEAK Surgical by Medtronic
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Macromastia (Symptomatic)

Keywords

  • Reduction mammaplasty
  • Breast reduction
  • PlasmaBlade
  • PEAK
03

In context

Lead sponsor

Medtronic Surgical Technologies is the lead sponsor of 14 studies on the registry; none are open to participants now.

Browse Medtronic Surgical Technologies studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age between 18 and 70
  2. Physically healthy, stable weight
  3. No smoking \<1 month prior to surgery and during study.
  4. Desiring bilateral breast reduction
  5. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
  6. Subject must be willing and able to comply with specified follow-up evaluations.
  7. 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.

Exclusion criteria

Exclusion Criteria:

  1. Age younger than 18 or greater than 70 years old
  2. Anticoagulation therapy which cannot be discontinued
  3. Smoking \<1 month prior to surgery or during study
  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    PEAK PlasmaBlade

    Device: PEAK PlasmaBlade

  • Active comparator
    Standard of Care

    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

  • DevicePEAK PlasmaBlade
  • ProcedureScalpel and Traditional Electrosurgery
06

What researchers measure

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.

    Time frame: 24 hours and first 10 days post-op

Secondary outcomes

  1. Operative performance

    Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.

    Time frame: Intraoperatively on day 0

  2. Adverse events

    Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.

    Time frame: 1 month post-operatively

  3. Cutaneous scarring

    Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.

    Time frame: Up to one year post-operatively

07

Study locations

1 site
  • Gonyon Cosmetic & Plastic Surgery, PC
    Johnstown, Colorado 80534, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Oct 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2011
First posted
Jul 28, 2011
Start
May 2011
Primary completionActual
Oct 2011
CompletionActual
Nov 2011
Last update
Jan 7, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01404351
Lead sponsor
Medtronic Surgical Technologies
Responsible party
Sponsor
First posted
Jul 28, 2011
Start date
May 2011
Primary completion
Oct 2011
Completion
Nov 2011
Last update
Jan 7, 2013

Study contacts

Denis Gonyon, MD
principal investigator · Gonyon Cosmetic & Plastic Surgery, PC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Gigantomastia

Other studies from this sponsor

Medtronic Surgical Technologies →

Start the discussion