MacromastiaPRECISENCT00986453
PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
A study testing PEAK PlasmaBlade and Traditional Electrosurgery with scalpel in people with Macromastia, run by Medtronic Surgical Technologies at 7 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Macromastia
- What is being tested?
- PEAK PlasmaBlade and Traditional Electrosurgery with scalpel
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Providence St. Joseph's
Burbank, California, 91505
University Hospitals
Cleveland, Ohio, 44106
Verdugo Hills Hospital
Glendale, California, 91218
El Camino Hospital
Mountain View, California, 94040
Tri-City Medical Center
Oceanside, California, 92056
Sharp Outpatient Pavilion
San Diego, California, 92123
Rancho Bernardo Surgery Center
San Diego, California, 92128
About this study
Official title: A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
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).
Read the 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
- Being tested
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Keywords
- Breast Reduction, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Medical subject headings
- Gigantomastia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAK PlasmaBladeDevice
Also called PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
Traditional Electrosurgery with scalpelProcedure or surgery
Also called Scalpel, Electrosurgery, SOC
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
| Study group | Role | What they receive |
|---|---|---|
| PlasmaBlade arm | Experimental | The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision. Receives: Device: PEAK PlasmaBlade |
| Standard of Care | Active comparator | Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. Receives: Procedure: Traditional Electrosurgery with scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 10 days postoperative
Secondary outcomes (4)
Estimated Blood Loss
Measured: Intraoperative
Operative Time
Measured: Intraoperative
Amount of Tissue Removed
Measured: Intraoperative
Dissection Performance
Amount of tissue (g) removed over time (min)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MacromastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abhay Gupta, MD, Principal investigator, Gupta Plastic SurgeryHoward Rosenberg, MD, Principal investigator, Accent on Aesthetics Plastic SurgerySusan Downey, MD, Principal investigator, Susan Downey, MD, FACSLarry Pollack, MD, Principal investigator, Del Mar Plastic SurgeryHooman Soltanian, MD, Principal investigator, University Hospital Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986453
- Sponsor's protocol ID
- PEAK VP-00065
- Acronym
- PRECISE
- Status last verified
- Nov 2012
- First submitted
- 28 Sep 2009
- Last updated
- 1 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
- ClinicalTrials.gov ID
- NCT00986453
- Acronym / sponsor ID
- PRECISE / PEAK VP-00065
- Conditions
- Macromastia
- Keywords
- Breast Reduction, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Posted 1 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PlasmaBlade arm | Experimental | Device: PEAK PlasmaBladeThe PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision. |
| Standard of Care | Active comparator | Procedure: Traditional Electrosurgery with scalpelScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAK PlasmaBladeAlso: PlasmaBladeThe PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision. | Device | PlasmaBlade arm |
| Traditional Electrosurgery with scalpelAlso: Scalpel, Electrosurgery, SOCScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. | Procedure or surgery | Standard of Care |
Primary outcome
Postoperative Pain
Time frame: 0 to 10 days postoperative
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.
4 secondary outcomes
Estimated Blood Loss
Time frame: Intraoperative
Operative Time
Time frame: Intraoperative
Amount of Tissue Removed
Time frame: Intraoperative
Dissection Performance
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Macromastia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhay Gupta, MD principal investigator
Gupta Plastic Surgery
Howard Rosenberg, MD principal investigator
Accent on Aesthetics Plastic Surgery
Susan Downey, MD principal investigator
Susan Downey, MD, FACS
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAK PlasmaBlade and Traditional Electrosurgery with scalpel in people with Macromastia, run by Medtronic Surgical Technologies at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 0 to 10 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2013; AzTrials last refreshed its copy on 31 Oct 2026.