Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
Public ClinicalTrials.gov record NCT03463954. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03463954
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 122 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 8, 2023
- Primary completion
- Dec 30, 2026
- Completion
- Mar 29, 2027
- Last update posted
- Feb 18, 2026
2023 – 2027
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | Withdrawn |
| UC San Diego Health | La Jolla | California | 92037 | Recruiting |
| Eisenhower Health | Rancho Mirage | California | 92270 | Recruiting |
| Yale University | New Haven | Connecticut | 06511 | Recruiting |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | Withdrawn |
| Summit Health | Florham Park | New Jersey | 07932 | Not yet recruiting |
| Buffalo General Medical Center | Buffalo | New York | 14203 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03463954, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 18, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03463954 live on ClinicalTrials.gov.