MacromastiaPRECISENCT01284491
A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
A study testing PEAK PlasmaBlade 4.0 and Traditional Electrosurgery with scalpel in people with Macromastia, run by Medtronic Surgical Technologies at 1 site in United States.
Trial summary
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Macromastia
- What is being tested?
- PEAK PlasmaBlade 4.0 and Traditional Electrosurgery with scalpel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70
- Physically healthy, stable weight
- Non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery.
- 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.
- Subjects who have participated in the PEAK PlasmaBlade bilateral breast reduction study.
Who cannot join
- Age younger than 18 or greater than 70 years old
- Anticoagulation therapy which cannot be discontinued
- Smoking (continuous; any substance)
- Infection (local or systemic)
- Cognitive impairment or mental illness
- Severe cardiopulmonary deficiencies
Show all 13Show fewer
- Known coagulopathy
- Immunocompromised
- Prior history of breast cancer
- Kidney disease (any type)
- Currently taking any medication known to affect healing
- Subjects who did not participated in the PEAK PlasmaBlade bilateral breast reduction study
- Unable to follow instructions or complete follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel.
Read the detailed description
Subjects attended one of two evaluation dates scheduled on January 21, 2011 and February 23, 2011. During this visit, subjects gave informed consent and were instructed on evaluating their breast reduction scars using the Patient Scar Assessment Scale. Following subjects' self-evaluation, each subject was evaluated by three evaluators using the Observer Scar Assessment Scale.
- Conditions
- Macromastia
- Being tested
- PEAK PlasmaBlade 4.0, 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 PlasmaBlade 4.0Device
Also called PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
Traditional Electrosurgery with scalpelDevice
Also called Scalpel and electrosurgery, SOC
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. Receives: Device: Traditional Electrosurgery with scalpel |
| PlasmaBlade | Experimental | The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision. Receives: Device: PEAK PlasmaBlade 4.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Quality
The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.
Measured: 0-18 months following breast reduction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Termination due to acquisition of PEAK Surgical by Medtronic
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 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 Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284491
- Sponsor's protocol ID
- PEAK VP-00070
- Acronym
- PRECISE
- Status last verified
- Jan 2013
- First submitted
- 25 Jan 2011
- Last updated
- 8 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 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
- ClinicalTrials.gov ID
- NCT01284491
- Acronym / sponsor ID
- PRECISE / PEAK VP-00070
- Conditions
- Macromastia
- Keywords
- Breast reduction, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination due to acquisition of PEAK Surgical by Medtronic
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Posted 3 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 scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel.
Detailed description
Subjects attended one of two evaluation dates scheduled on January 21, 2011 and February 23, 2011. During this visit, subjects gave informed consent and were instructed on evaluating their breast reduction scars using the Patient Scar Assessment Scale. Following subjects' self-evaluation, each subject was evaluated by three evaluators using the Observer Scar Assessment Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Device: Traditional Electrosurgery with scalpelScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. |
| PlasmaBlade | Experimental | Device: PEAK PlasmaBlade 4.0The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70
- Physically healthy, stable weight
- Non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery.
- 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 (13 listed)
- Age younger than 18 or greater than 70 years old
- Anticoagulation therapy which cannot be discontinued
- Smoking (continuous; any substance)
- 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 4.0Also: PlasmaBladeThe PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision. | Device | PlasmaBlade |
| Traditional Electrosurgery with scalpelAlso: Scalpel and electrosurgery, SOCScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. | Device | Standard of Care (SOC) |
Primary outcome
Scar Quality
Time frame: 0-18 months following breast reduction surgery
The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
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 4.0 and Traditional Electrosurgery with scalpel in people with Macromastia, 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 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?
Yes. Results are posted in the registry (first posted 3 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?
Scar Quality (time frame: 0-18 months following breast reduction surgery). 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 8 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.