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Palm Beach Country Breast Specialist Dr. Robert A. Gardner, MD, FACS

Clinical Studies

ABLATE Study
Clinical Research Study for Benign Breast Tumor

Are You Considering Surgery for a Benign Breast Tumor?

A clinical research study is offering qualified registry participants an FDA-cleared minimally invasive alternative to surgical lumpectomy at no cost.

The ABLATE Study: Striving to make a Difference

The American Breast Laser Ablation Tracking Evaluation (ABLATE) study registry will track volunteers who undergo Novilase interstitial laser therapy (ILT) for benign breast tumors. Consider joining the hundreds of women expected to take part in this study and report their progress over several years.  You can share in the hope that what researchers discover during the study may lead to new and improved breast cancer treatment techniques that may help millions of women worldwide.

A Minimally Invasive Alternative to Lumpectomy Surgery

Have you been diagnosed with a benign breast tumor, or fibroadenoma? Are you anxious about the growth in your breast? Maybe you’ve even discussed surgical removal with your doctor. If so, you may want to consider another option: The ABLATE study using the FDA-cleared Novilase procedure. The Novilase procedure uses precision laser technology to eliminate breast fibroadenomas without an invasive surgical procedure, hospital admission, general anesthesia or stitches.

The Novilase procedure:

  • Lowers risks associated with conventional surgery

  • Reduces recovery time compared with lumpectomy

  • Takes an hour or less to complete in an outpatient setting

  • Preserves the natural contours of your breast with minimal scarring

Do I Qualify for the ABLATE Study?

You may qualify to join the ABLATE study and patient registry if you can answer yes to the following questions:

  • Are you 18 years of age or older

  • Have you been diagnosed with one or more benign breast fibroadenomas?

  • Were your fibroadenoma(s) detected either by physical exam or imaging?

  • Has your diagnosis been confirmed by needle core biopsy?

  • When you volunteer and qualify for the ABLATE study, and enroll in the patient registry, you will receive the Novilase procedure at no cost.

What Can I Expect from Study Participation?

As a qualified participant in the ABLATE study you will undergo the FDA-cleared Novilase procedure at no cost to you. The Novilase procedure uses precision laser technology to eliminate breast tumors through 1/8” nicks that can be closed with a band-aid. The body’s natural repair process replaces breast tissue over time. The procedure takes between 30-60 minutes and you can drive yourself home after it is completed.

After undergoing the Novilase procedure, you will be asked to make periodic medical visits so that doctors can track your progress for which you will be compensated for the time and travel.

Consider helping research. Consider volunteering.

ABLATE

Inclusion Criteria:
  • Patient is 18 years of age or older

  • Diagnosis confirmed by 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 verbal consent prior to being treated with Novilase

  • Papiloma

  • Lipoma

Exclusion Criteria:
  • Patient is under 18 years of age

  • Patient is pregnant or lactating

  • Hypercellularity suggestive of phylloides

  • Atypia

  • Equivocal pathologie report(e.g. discordance between radiographic and microscopic results)

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