American Breast Laser Ablation Therapy Evaluation (ABLATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Novian Health Inc.
Information provided by (Responsible Party):
Novian Health Inc. Identifier:
First received: December 11, 2008
Last updated: October 16, 2014
Last verified: October 2014

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: 500
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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 Not yet 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, Illinois
Alexian Brothers Health System - Saint Alexius Breast Care Center Not yet recruiting
Bartlett, Illinois, United States, 60103
Contact: Robert Maganini, M.D.    847-755-8700   
Principal Investigator: Robert Maganini, M.D.         
Advocate Lutheran General Hospital - Caldwell Breast Center Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Heidi Memmel, M.D.    847-723-3100   
Principal Investigator: Heidi Memmel, M.D.         
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.         
United States, Ohio
The University of Toledo Recruiting
Toledo, Ohio, United States, 43606
Contact: Helen Mabry, M.D.         
Principal Investigator: Helen Mabry, M.D.         
Principal Investigator: Prabir K. Chaudhuri, M.D.         
United States, Wisconsin
Wheaton Franciscan Health System Not yet recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Hanadi Bu-Ali, M.D.    414-256-1920   
Contact: Jodi Brehm, M.D.    414-256-1920   
Principal Investigator: Hanadi Bu-Ali, M.D.         
Principal Investigator: Jodi Brehm, 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: October 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Novian Health Inc.:
Minimally invasive
Interstitial laser therapy
Laser ablation
Breast lesion
Breast tumor processed this record on March 26, 2015