Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRuidiaz 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 21744349