Study to Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade
A Prospective, Controlled Study To Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade Compared to Traditional Electrosurgery
1 other identifier
observational
21
1 country
3
Brief Summary
The purpose of this research study is to find out more about distinguishing between cancerous and non-cancerous breast cancer cells at the edges of tumors. Using an FDA approved device to remove tumors, this device will be tested to see if it causes less tissue damage and therefore makes it easier to examine the tumor and make sure it is all excised. The tumors will be excised by standard surgical technique, and then the effects of the device on the removed tissues will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2009
3 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
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 3, 2009
CompletedFirst Posted
Study publicly available on registry
September 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJuly 12, 2019
July 1, 2019
1 year
September 3, 2009
July 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the thermal injury artifact produced by traditional electrosurgery vs. the PEAK PlasmaBlade by intensive pathologic analysis both by gross inspection, touch imprint, and permanent histologic analysis.
1 year
Eligibility Criteria
Patients recruited from the Moores UCSD Cancer Center and the UCSD Medical Center
You may qualify if:
- Women or men with an established diagnosis of an invasive ductal carcinoma
- Women or men with tumors \> 1cm
- Women undergoing Breast Conservation Operations
- Women or men may have had prior chemotherapy as long as their treatment was completed \>2 weeks prior to enrollment with recovery from any toxicities
You may not qualify if:
- No established diagnosis of breast cancer
- Women or men with tumors \<1 cm
- Women or men undergoing total mastectomy
- Women or men who have had prior radiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sarah Blair, M.D.lead
- Medtronic Surgical Technologiescollaborator
Study Sites (3)
Thornton Hospital
La Jolla, California, 92037, United States
Rebecca and John Moores Cancer Center
La Jolla, California, 92093, United States
UCSD Medical Center
San Diego, California, 92103, United States
Related Publications (1)
Ruidiaz ME, Cortes-Mateos MJ, Sandoval S, Martin DT, Wang-Rodriguez J, Hasteh F, Wallace A, Vose JG, Kummel AC, Blair SL. Quantitative comparison of surgical margin histology following excision with traditional electrosurgery and a low-thermal-injury dissection device. J Surg Oncol. 2011 Dec;104(7):746-54. doi: 10.1002/jso.22012. Epub 2011 Jul 8.
PMID: 21744349DERIVED
Biospecimen
Breast tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah L Blair, MD
University of California, San Diego
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
September 3, 2009
First Posted
September 4, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2010
Study Completion
November 1, 2010
Last Updated
July 12, 2019
Record last verified: 2019-07