Study Stopped
Termination due to acquisition of PEAK Surgical by Medtronic
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
PRECISE
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy
1 other identifier
interventional
60
1 country
4
Brief 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 surgery; and to compare these endpoints to the current standard of care (SOC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2009
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
January 3, 2013
CompletedJanuary 8, 2013
January 1, 2013
2.5 years
July 21, 2009
November 29, 2012
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total Serous Drainage (mL) From Time of Drain Placement to Removal.
0 to 10 days postoperatively
Area of Skin Necrosis Measured With a Standard Ruler
1 and 6 weeks postoperative
Secondary Outcomes (1)
Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal
0 to 10 days postoperatively
Study Arms (2)
Standard of Care
ACTIVE COMPARATORScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
PEAK PlasmaBlade
EXPERIMENTALThe entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
Interventions
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Providence St. Joseph's Medical Center
Burbank, California, 94505, United States
El Camino Hospital
Mountain View, California, 94040, United States
Advanced Breast Care
Marietta, Georgia, 30060, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.
Results Point of Contact
- Title
- Robert Swain, PhD
- Organization
- Medtronic Surgical Technologies
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa Ponn, MD
Elliot Breast Health Center
- PRINCIPAL INVESTIGATOR
Edward Dalton, MD
Elliot Breast Health Center
- PRINCIPAL INVESTIGATOR
Richard Fine, MD
Advanced Breast Care
- PRINCIPAL INVESTIGATOR
Peter Naruns, MD
Midpeninsula Surgical Associates
- PRINCIPAL INVESTIGATOR
Saul Eisenstat, MD
Midpeninsula Surgical Associates
- PRINCIPAL INVESTIGATOR
Michael Schultz, MD
St. Joseph Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 22, 2009
Study Start
June 1, 2009
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
January 8, 2013
Results First Posted
January 3, 2013
Record last verified: 2013-01