ABLATE: American Breast Laser Ablation Therapy Evaluation

Sponsor

Novian Health Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT00807924

Collaborator

(none)

200

Enrollment

Location

150

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Breast Conditions; Breast Fibroadenomas

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Study Start Date :

Dec 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Outcome Measures

Primary Outcome Measures

To monitor and measure long term safety and effectiveness Novilase [ongoing]
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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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