CompletedNot Applicable

American Breast Laser Ablation Therapy Evaluation

United States108 participantsStarted 2008-12

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To monitor and measure long term safety and effectiveness Novilase

Timeframe: ongoing

To help refine, improve and/or validate breast tumor best practices and standard of care

Timeframe: ongoing

To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols

Timeframe: 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

Timeframe: ongoing

Trial details

NCT IDNCT00807924

SponsorNovian Health Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-08-28

View on ClinicalTrials.gov More Benign Breast Conditions; Breast Fibroadenomas trials