Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00972010
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Medtronic Surgical Technologies
Information provided by (Responsible Party):
Sarah Blair, M.D., University of California, San Diego

Tracking Information
First Submitted Date September 3, 2009
First Posted Date September 4, 2009
Last Update Posted Date July 12, 2019
Study Start Date July 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2009)
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. [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade
Official Title A Prospective, Controlled Study To Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade Compared to Traditional Electrosurgery
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.
Detailed Description

Breast conservation therapy (BCT) is the standard surgical treatment for breast cancer. The goal of BCT is total excision of the malignant lesion while simultaneously preserving the cosmetic appearance and functionality of the breast. Despite advances in technique and pathologic analysis; however, 20-50% of malignant breast lump excisions have cancer present to the edge of the excision margin (defined as a "positive" margin). Excisions that are found to be margin positive require a secondary excision; however, in these cases residual disease is found to be present in only 40-70% of cases. Some researchers have hypothesized that re-excision was unnecessary in a certain percentage of cases. Currently there are no routinely utilized method for intra-operative interpretation of surgical margins. Touch preps or imprint cytology has been used in the past in some centers but it is not used routinely because an experienced cytopathologist is needed to correctly interpret the slides.

The standard of care to evaluate surgical margins is based on permanent section. Margins are considered negative if there is greater than 1 mm of normal tissue between cancer cells to the excised surface. Many factors for this discrepancy have been postulated, including artifact associated with the inking process and with electrosurgery induced damage of the margin during excision (thermal injury); therefore, creating a "false positive" impression of tumor cells present at surgical margins. We propose a clinical study to evaluate the effects of thermal injury in breast cancer excision using traditional electrosurgery (i.e., the "Bovie") compared to the pulsed RF technology with the PEAK PlasmaBlade. We hypothesize that the PlasmaBlade will impart less thermal injury to the incised breast tissue (malignant and normal) and will increase the specificity of the margin status. The majority of breast cancers are removed by traditional electrocautery. We are just starting to utilize this new technology for soft tissue dissection at UCSD.

The PEAK PlasmaBlade is a family of disposable surgical cutting and coagulation devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage. The PlasmaBlade is based on proprietary pulsed plasma technology. This technology represents an evolutionary leap in the advancement of radiofrequency surgical technologies, which originated with traditional electrosurgery and progressed to plasma-mediated energy devices. The PlasmaBlade tissue dissection devices are FDA-cleared and commercially available.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Breast tissue
Sampling Method Non-Probability Sample
Study Population Patients recruited from the Moores UCSD Cancer Center and the UCSD Medical Center
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 9, 2010)
21
Original Estimated Enrollment
 (submitted: September 3, 2009)
20
Actual Study Completion Date November 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00972010
Other Study ID Numbers 090314
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sarah Blair, M.D., University of California, San Diego
Study Sponsor Sarah Blair, M.D.
Collaborators Medtronic Surgical Technologies
Investigators
Principal Investigator: Sarah L Blair, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date July 2019