Clinical Trial: American Breast Laser Ablation Therapy Evaluation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application
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 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.
Sponsor: Novian Health Inc.
Current Primary Outcome:
- To monitor and measure long term safety and effectiveness Novilase [ Time Frame: ongoing ]
- To help refine, improve and/or validate breast tumor best practices and standard of care [ Time Frame: ongoing ]
- To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols [ Time Frame: ongoing ]
- To support the medical and patient communities through transparency--by contributing and publishing relevant, useful and meaningful data to support the development and design of future research [ Time Frame: ongoing ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Novian Health Inc.
Dates:
Date Received: December 11, 2008
Date Started: December 2008
Date Completion: December 2018
Last Updated: March 30, 2017
Last Verified: March 2017
