Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors (NCT03463954)
Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- City of Hope — Duarte, California
- UC San Diego Health — La Jolla, California
- Eisenhower Health — Rancho Mirage, California
- Yale University — New Haven, Connecticut
- Walter Reed National Military Medical Center — Bethesda, Maryland
- Summit Health — Florham Park, New Jersey
- Buffalo General Medical Center — Buffalo, New York
- St. Elisabeth-Krankenhaus Köln-Hohenlind — Cologne,
- Ichilov | Tel Aviv Sourasky Medical Center — Tel Aviv,
- Breast Centre Zurich — Zurich,
- University Hospital Zurich — Zurich,
- Charing Cross Hospital, Imperial College Healthcare NHS Trust — London,
- Churchill Hospital, Oxford University Hospitals NHS Trust — Oxford,
📞 Contact the Study Coordinator
Phone: (312) 266-7200
Email: ebajorinas@novianhealth.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.