American Breast Laser Ablation Therapy Evaluation

Completed

• Conditions: Benign Breast Conditions; Breast Fibroadenomas

• Registration Number: NCT00807924
• Lead Sponsor: Novian Health Inc.

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, 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-11
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Primary Completion: 2017-08-28
• Study Completion: 2018-08-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To help refine, improve and/or validate breast tumor best practices and standard of care	ongoing
To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols	ongoing
To monitor and measure long term safety and effectiveness Novilase	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	ongoing

Trial Locations

Locations (1)

Columbia University Medical Center - Department of Surgery; 🇺🇸 New York, New York, United States