American Breast Laser Ablation Therapy Evaluation (ABLATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Novian Health Inc.
Information provided by (Responsible Party):
Novian Health Inc. Identifier:
First received: December 11, 2008
Last updated: March 21, 2016
Last verified: March 2016
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.

Benign Breast Conditions; Breast Fibroadenomas

Study Type: Observational
Study Design: 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

Further study details as provided by Novian Health Inc.:

Primary Outcome Measures:
  • To monitor and measure long term safety and effectiveness Novilase [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • To help refine, improve and/or validate breast tumor best practices and standard of care [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2008
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00807924

Contact: Marti DeLay 312-266-7200
Contact: Eugene Bajorinas 312-266-7200

United States, Arizona
The Breast Center of Southern Arizona Recruiting
Tucson, Arizona, United States, 85712
Contact: Eric Whitacre, M.D.    520-319-6686      
Principal Investigator: Eric Whitacre, M.D.         
United States, Colorado
Rose Medical Center - Rose Breast Center Recruiting
Denver, Colorado, United States, 80220
Contact: Barbara Schwartzberg, M.D.    303-320-7127   
Principal Investigator: Barbara Schwartzberg, MD         
United States, New York
Columbia University Medical Center - Department of Surgery Recruiting
New York City, New York, United States, 10032
Contact: Margaret Chen, M.D.    212-305-9676      
Principal Investigator: Margaret Chen, M.D.         
Sub-Investigator: Sheldon Feldman, M.D.         
Sub-Investigator: Bret Taback, M.D.         
Sub-Investigator: Preya Ananthakrishnan, M.D.         
Sponsors and Collaborators
Novian Health Inc.
Principal Investigator: Barbara Schwartzberg, MD Rose Medical Center - Rose Breast Center
  More Information

Additional Information:
Responsible Party: Novian Health Inc. Identifier: NCT00807924     History of Changes
Other Study ID Numbers: BR001 
Study First Received: December 11, 2008
Last Updated: March 21, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Novian Health Inc.:
Minimally invasive
Interstitial laser therapy
Laser ablation
Breast lesion
Breast tumor

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Glandular and Epithelial processed this record on May 24, 2016