New York, New York 10032


Purpose:

The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.


Study summary:

ABLATE is a prospective, observational multi-center tracking database which will evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked.


Criteria:

Inclusion Criteria: - Diagnosis confirmed by needle core biopsy - Tumors detected either by physical exam or imaging - Tumors do not exceed 2 cm in diameter and measure at least 0.5 cm away from the skin and chest wall - Single, multiple and/or bilateral tumors - Patient has given consent prior to being treated with Novilase™ Exclusion Criteria: - Patient is pregnant or lactating - Hypercellularity suggestive of phyllodes - Atypia - Equivocal pathology report (e.g., discordance between radiographic and microscopic results) - Fibroadenomas with stromal solidarity


NCT ID:

NCT00807924


Primary Contact:

Principal Investigator
Barbara Schwartzberg, MD
Rose Medical Center - Rose Breast Center

Marti DeLay
Phone: 312-266-7200
Email: info@novianhealth.com


Backup Contact:

Email: info@novianhealth.com
Eugene Bajorinas
Phone: 312-266-7200


Location Contact:

New York, New York 10032
United States

Margaret Chen, M.D.
Phone: 212-305-9676

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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