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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00807924

Acronym

ABLATE

Enrollment

108

Registered

2008-12-12

Start date

2008-12-31

Completion date

2018-08-08

Last updated

2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Breast Conditions; Breast Fibroadenomas

Keywords

Fibroadenomas, Papillomas, Breast, Minimally invasive, Interstitial laser therapy, Laser ablation, Benign, Non-cancerous, Breast lesion, Breast tumor

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To help refine, improve and/or validate breast tumor best practices and standard of care	ongoing
To monitor and measure long term safety and effectiveness Novilase	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

Countries

United States

Outcome results