NCT03718442 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

ACS
Breast Cancer Facts and Figures 2011-2012. (2012).
Chiappa C, Rovera F, Corben AD, Fachinetti A, De Berardinis V, Marchionini V, Rausei S, Boni L, Dionigi G, Dionigi R
Surgical margins in breast conservation. Int J Surg. 2013;11 Suppl 1:S69-72. doi: 10.1016/S1743-9191(13)60021-7. Review.
Haydon E
et al. Assessment of penetrating thermal tissue damage/spread associated with PhotonBlade™, Valleylab™ Pencil, Valleylab™ EDGE™ Coated Pencil, PlasmaBlade® 3.0S and PlasmaBlade® 4.0 for intraoperative tissue dissection using the fresh extirpated porcine muscle model
Pleijhuis RG, Graafland M, de Vries J, Bart J, de Jong JS, van Dam GM
Obtaining adequate surgical margins in breast-conserving therapy for patients with early-stage breast cancer: current modalities and future directions. Ann Surg Oncol. 2009 Oct;16(10):2717-30. doi: 10.1245/s10434-009-0609-z. Epub 2009 Jul 17. Review.
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.
Vila J, Gandini S, Gentilini O
Overall survival according to type of surgery in young (=40 years) early breast cancer patients: A systematic meta-analysis comparing breast-conserving surgery versus mastectomy. Breast. 2015 Jun;24(3):175-81. doi: 10.1016/j.breast.2015.02.002. Epub 2015 Feb 23. Review.

Low Energy Dissection Vs. Electrocautery Qualitative Severity and Depth of Thermal Artifact in Breast Cancer Lumpectomy Shaved Surgical Margins

Details for clinical trial NCT03718442

Clinical trial NCT03718442 - References