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Completed

NCT Number: NCT00807924

American Breast Laser Ablation Therapy Evaluation

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.

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Key information

Conditions

Benign Breast Conditions; Breast Fibroadenomas Breast Diseases Breast Neoplasms Fibroadenoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Papilloma Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Columbia University Medical Center - Department of Surgery

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To monitor and measure long term safety and effectiveness Novilase

    Time frame: ongoing

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

    Time frame: ongoing

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

    Time frame: ongoing

  4. 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

Sponsors and collaborators

Lead sponsor

Novian Health Inc.

Industry

Registry information

Official study 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

Acronym: ABLATE

Important dates

Study start
2008
Primary completion
2017
Study completion
2018
First posted
Dec 12, 2008
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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