Macromastia (Symptomatic)NCT01404351
Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
A study testing PEAK PlasmaBlade and Scalpel and Traditional Electrosurgery in people with Macromastia (Symptomatic), run by Medtronic Surgical Technologies at 1 site 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 to compare these outcomes to the HARMONIC SYNERGY® BLADE. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Macromastia (Symptomatic)
- What is being tested?
- PEAK PlasmaBlade and Scalpel and Traditional Electrosurgery
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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
1 site in 1 country.
United States1 site
Gonyon Cosmetic & Plastic Surgery, PC
Johnstown, Colorado, 80534
About this study
Official title: A Prospective, Randomized, Controlled Superiority 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 to compare these outcomes to the HARMONIC SYNERGY® BLADE.
- Conditions
- Macromastia (Symptomatic)
- Being tested
- PEAK PlasmaBlade, Scalpel and Traditional Electrosurgery
- Keywords
- Reduction mammaplasty, Breast reduction, PlasmaBlade, PEAK
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAK PlasmaBladeDevice
Scalpel and Traditional ElectrosurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PEAK PlasmaBlade | Experimental | Not described Receives: 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. Receives: Procedure: Scalpel and Traditional Electrosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours and first 10 days post-op
Secondary outcomes (3)
Operative performance
Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.
Measured: Intraoperatively on day 0
Adverse events
Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.
Measured: 1 month post-operatively
Cutaneous scarring
Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.
Measured: Up to one year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionNov 2011
Why it stopped: Study terminated due to the acquisition of PEAK Surgical by Medtronic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macromastia (Symptomatic)Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis Gonyon, MD, Principal investigator, Gonyon Cosmetic & Plastic Surgery, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404351
- Sponsor's protocol ID
- VP-00133
- Status last verified
- Jan 2013
- First submitted
- 25 Jul 2011
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction
- ClinicalTrials.gov ID
- NCT01404351
- Acronym / sponsor ID
- VP-00133
- Conditions
- Macromastia (Symptomatic)
- Keywords
- Reduction mammaplasty, Breast reduction, PlasmaBlade, PEAK
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated due to the acquisition of PEAK Surgical by Medtronic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
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 to compare these outcomes to the HARMONIC SYNERGY® BLADE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEAK PlasmaBlade | Experimental | Device: PEAK PlasmaBlade |
| Standard of Care | Active comparator | Procedure: Scalpel and Traditional ElectrosurgeryThe Standard of Care arm will consist of the scalpel for the skin incision and traditional electrosurgery for subcutaneous dissection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
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 PlasmaBlade | Device | PEAK PlasmaBlade |
| Scalpel and Traditional Electrosurgery | Procedure or surgery | Standard of Care |
Primary outcome
Difference in pain
Time frame: 24 hours and first 10 days post-op
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.
3 secondary outcomes
Operative performance
Time frame: Intraoperatively on day 0
Adverse events
Time frame: 1 month post-operatively
Cutaneous scarring
Time frame: Up to one year post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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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.
Denis Gonyon, MD principal investigator
Gonyon Cosmetic & Plastic Surgery, PC
1 site 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 Scalpel and Traditional Electrosurgery in people with Macromastia (Symptomatic), run by Medtronic Surgical Technologies at 1 site 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 7 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: withdrawn, as of the sponsor's last update on 7 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 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Difference in pain (time frame: 24 hours and first 10 days post-op). 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 7 Jan 2013.