Condition: Malignant Neoplasm of Breast · Sponsor: Novian Health Inc.
Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.
This description comes directly from the study's public registry record.
Eugene Bajorinas · 3122667200 · ebajorinas@novianhealth.com
Chip Appelbaum · 3122667200 · info@novianhealth.com
Always discuss trial participation with your own doctor first.
| City of Hope | Duarte, California, United States | Withdrawn |
| UC San Diego Health | La Jolla, California, United States | Recruiting |
| Eisenhower Health | Rancho Mirage, California, United States | Recruiting |
| Yale University | New Haven, Connecticut, United States | Recruiting |
| Walter Reed National Military Medical Center | Bethesda, Maryland, United States | Withdrawn |
| Summit Health | Florham Park, New Jersey, United States | Not Yet Recruiting |
| Buffalo General Medical Center | Buffalo, New York, United States | Recruiting |
| St. Elisabeth-Krankenhaus Köln-Hohenlind | Cologne, Germany | Recruiting |
| Ichilov | Tel Aviv Sourasky Medical Center | Tel Aviv, Israel | Recruiting |
| Breast Centre Zurich | Zurich, Switzerland | Terminated |
| University Hospital Zurich | Zurich, Switzerland | Recruiting |
| Charing Cross Hospital, Imperial College Healthcare NHS Trust | London, United Kingdom | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03463954