Status:
COMPLETED
American Breast Laser Ablation Therapy Evaluation
Lead Sponsor:
Novian Health Inc.
Conditions:
Benign Breast Conditions; Breast Fibroadenomas
Eligibility:
FEMALE
18+ years
Brief Summary
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.
Detailed Description
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, papillom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 8 2018
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00807924
Start Date
December 1 2008
End Date
August 8 2018
Last Update
August 4 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Medical Center - Department of Surgery
New York, New York, United States, 10032