MastectomyPRECISENCT00943605
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
A study testing Scalpel and Traditional Electrosurgery and PEAK PlasmaBlade in people with Mastectomy, run by Medtronic Surgical Technologies at 4 sites in United States.
Trial summary
The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Mastectomy
- What is being tested?
- Scalpel and Traditional Electrosurgery and PEAK PlasmaBlade
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2009to Mar 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 70 years old
- Physically healthy, stable weight
- Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy
- 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 all follow-up evaluations
Who cannot join
- Age younger than 20 or greater than 70 years old
- Anticoagulation therapy which cannot be discontinued
- Prior external beam or implanted radiotherapy
- Tobacco use (any kind)
- Infection (local or systemic)
- Cognitive impairment or mental illness
Show all 17Show fewer
- Severe cardiopulmonary deficiencies
- Known coagulopathy
- Immunocompromised
- Kidney disease (any type)
- Desiring or requiring same-day breast reconstruction
- Prior breast reduction or augmentation surgery
- Unable to follow instructions or complete follow-up
- 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
- Time from most recent neoadjuvant therapy less than 4 weeks
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Providence St. Joseph's Medical Center
Burbank, California, 94505
Advanced Breast Care
Marietta, Georgia, 30060
El Camino Hospital
Mountain View, California, 94040
St. Joseph Medical Center
Towson, Maryland, 21204
About this study
Official title: A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy
The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care (SOC).
Read the detailed description
Mastectomy is a surgical procedure performed to remove breast tissue that contains cancer, or has a high probability of containing cancer. During the procedure, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away the breast tissue from the chest and control bleeding. Once the breast tissue is removed the remaining skin edges are brought together with sutures.
Following mastectomy, the most common complication is persistent serous wound drainage and seroma, a collection of fluid in the closed surgical space. To help prevent this complication a tissue drain is used to remove serous fluid from the surgical space via bulb suction. The rate of serous fluid collection is used to determine the time the drain remains in place. Although suction drains help reduce seroma formation, prolonged use may delay healing, cause injury, and increase the risk of infection and patient discomfort.
The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and coagulating at the point of application, without the thermal damage to surrounding tissues that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA clearance for use in plastic, general, and ENT surgery, and has demonstrated significantly reduced serous drainage in tissue reduction surgeries, like mastectomy.
This multi-site study was granted IRB approval and conducted between June 2009 and January 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were then required to provide informed consent prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for mastectomy with or without same day reconstruction.
- Conditions
- Mastectomy
- Being tested
- Scalpel and Traditional Electrosurgery, PEAK PlasmaBlade
- Keywords
- Mastectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalpel and Traditional ElectrosurgeryDevice
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
PEAK PlasmaBladeDevice
The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. Receives: Device: Scalpel and Traditional Electrosurgery |
| PEAK PlasmaBlade | Experimental | The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision. Receives: Device: PEAK PlasmaBlade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Serous Drainage (mL) From Time of Drain Placement to Removal.
Measured: 0 to 10 days postoperatively
Area of Skin Necrosis Measured With a Standard Ruler
Measured: 1 and 6 weeks postoperative
Secondary outcomes (1)
Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal
Measured: 0 to 10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionMar 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 MastectomyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teresa Ponn, MD, Principal investigator, Elliot Breast Health CenterEdward Dalton, MD, Principal investigator, Elliot Breast Health CenterRichard Fine, MD, Principal investigator, Advanced Breast CarePeter Naruns, MD, Principal investigator, Midpeninsula Surgical AssociatesSaul Eisenstat, MD, Principal investigator, Midpeninsula Surgical AssociatesMichael Schultz, MD, Principal investigator, St. Joseph Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943605
- Sponsor's protocol ID
- PEAK VP-00074
- Acronym
- PRECISE
- Status last verified
- Jan 2013
- First submitted
- 21 Jul 2009
- 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 Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy
- ClinicalTrials.gov ID
- NCT00943605
- Acronym / sponsor ID
- PRECISE / PEAK VP-00074
- Conditions
- Mastectomy
- Keywords
- Mastectomy, 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
- 60 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Jul 2009 (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 the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care (SOC).
Detailed description
Mastectomy is a surgical procedure performed to remove breast tissue that contains cancer, or has a high probability of containing cancer. During the procedure, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away the breast tissue from the chest and control bleeding. Once the breast tissue is removed the remaining skin edges are brought together with sutures.
Following mastectomy, the most common complication is persistent serous wound drainage and seroma, a collection of fluid in the closed surgical space. To help prevent this complication a tissue drain is used to remove serous fluid from the surgical space via bulb suction. The rate of serous fluid collection is used to determine the time the drain remains in place. Although suction drains help reduce seroma formation, prolonged use may delay healing, cause injury, and increase the risk of infection and patient discomfort.
The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and coagulating at the point of application, without the thermal damage to surrounding tissues that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA clearance for use in plastic, general, and ENT surgery, and has demonstrated significantly reduced serous drainage in tissue reduction surgeries, like mastectomy.
This multi-site study was granted IRB approval and conducted between June 2009 and January 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were then required to provide informed consent prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for mastectomy with or without same day reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Device: Scalpel and Traditional ElectrosurgeryScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. |
| PEAK PlasmaBlade | Experimental | Device: PEAK PlasmaBladeThe entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 20 and 70 years old
- Physically healthy, stable weight
- Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy
- 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 all follow-up evaluations
Key exclusion criteria (17 listed)
- Age younger than 20 or greater than 70 years old
- Anticoagulation therapy which cannot be discontinued
- Prior external beam or implanted radiotherapy
- Tobacco use (any kind)
- Infection (local or systemic)
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 |
|---|---|---|
| Scalpel and Traditional ElectrosurgeryThe PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision. | Device | Standard of Care |
| PEAK PlasmaBladeThe entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision. | Device | PEAK PlasmaBlade |
Primary outcome
Total Serous Drainage (mL) From Time of Drain Placement to Removal.
Time frame: 0 to 10 days postoperatively
Area of Skin Necrosis Measured With a Standard Ruler
Time frame: 1 and 6 weeks postoperative
1 secondary outcome
Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal
Time frame: 0 to 10 days postoperatively
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.
Teresa Ponn, MD principal investigator
Elliot Breast Health Center
Edward Dalton, MD principal investigator
Elliot Breast Health Center
Richard Fine, MD principal investigator
Advanced Breast Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalpel and Traditional Electrosurgery and PEAK PlasmaBlade in people with Mastectomy, run by Medtronic Surgical Technologies at 4 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 5 inclusion and 17 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 4 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 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?
Total Serous Drainage (mL) From Time of Drain Placement to Removal. (time frame: 0 to 10 days postoperatively). The study lists 2 primary outcomes in all. 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.