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American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application


N/A
18 Years
N/A
Open (Enrolling)
Female
Benign Breast Conditions; Breast Fibroadenomas

Thank you

Trial Information

American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

John Lewin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Diversified Radiology of Colorado

Authority:

United States: Institutional Review Board

Study ID:

BR001

NCT ID:

NCT00807924

Start Date:

December 2008

Completion Date:

December 2012

Related Keywords:

  • Benign Breast Conditions; Breast Fibroadenomas
  • Fibroadenomas
  • Papillomas
  • Breast
  • Minimally invasive
  • Interstitial laser therapy
  • Laser ablation
  • Benign
  • Non-cancerous
  • Breast lesion
  • Breast tumor
  • Fibroadenoma

Name

Location
Rose Breast Center Denver, Colorado  80220
New York Hospital Queens Flushing, New York  11355