St. Elisabeth-Krankenhaus Köln-Hohenlind 50935 Cologne (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsHeidelberg University Hospital 69120 Heidelberg (Baden-Württemberg) GermanyNoch nicht rekrutierend» Google-MapsCity of Hope 91010 Duarte United StatesRekrutierend» Google-Maps Ansprechpartner: Basak Gokcora E-Mail: bgokcora@coh.org» Ansprechpartner anzeigen
UC San Diego Health 92037 La Jolla United StatesRekrutierend» Google-MapsYale University 06511 New Haven United StatesRekrutierend» Google-Maps Ansprechpartner: Kristen DeFrancesco Phone: 203-785-3852 E-Mail: kristin.defrancesco@yale.edu» Ansprechpartner anzeigenWalter Reed National Military Medical Center 20889 Bethesda United StatesRekrutierend» Google-MapsSummit Health 07932 Florham Park United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Michelle McKenzie, RN Phone: 973-436-1755 E-Mail: mmackenzie@summithealth.com» Ansprechpartner anzeigenBuffalo General Medical Center 14203 Buffalo United StatesRekrutierend» Google-Maps Ansprechpartner: Gabriel Rubio E-Mail: Grubio@gppconline.com» Ansprechpartner anzeigenBreast Centre Zurich 8008 Zurich SwitzerlandRekrutierend» Google-MapsUniversity Hospital Zurich 8091 Zurich SwitzerlandRekrutierend» Google-Maps
1. Percentage of target tumors completely ablated in one procedure (Time Frame - 4-6 weeks): Efficacy: Rate of complete ablation by Novilase laser ablation
2. Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery (Time Frame - 4-6 weeks): Safety: frequency of AEs
Secondary outcome:
1. Patient reported rate of return to activities of daily living post-laser ablation and post-surgery (Time Frame - 4-6 weeks): Rate of recovery
2. Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks) (Time Frame - 4-6 weeks): Post-procedure cosmetic satisfaction
3. Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery) (Time Frame - 4-6 weeks): Health-related quality of life outcome measures