Trials / Completed
CompletedNCT00807924
American Breast Laser Ablation Therapy Evaluation
American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 108 (actual)
- Sponsor
- Novian Health Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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, 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.
Conditions
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2017-08-28
- Completion
- 2018-08-08
- First posted
- 2008-12-12
- Last updated
- 2023-08-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00807924. Inclusion in this directory is not an endorsement.