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American Breast Laser Ablation Therapy Evaluation (ABLATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00807924
Recruitment Status : Recruiting
First Posted : December 12, 2008
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Benign Breast Conditions; Breast Fibroadenomas

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.

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : December 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807924


Contacts
Contact: Marti DeLay 312-266-7200 info@novianhealth.com
Contact: Eugene Bajorinas 312-266-7200 info@novianhealth.com

Locations
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    info@novianhealth.com   
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.
Investigators
Principal Investigator: Barbara Schwartzberg, MD Rose Medical Center - Rose Breast Center
More Information

Additional Information:
Publications:
Responsible Party: Novian Health Inc.
ClinicalTrials.gov Identifier: NCT00807924     History of Changes
Other Study ID Numbers: BR001
First Posted: December 12, 2008    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Novian Health Inc.:
Fibroadenomas
Papillomas
Breast
Minimally invasive
Interstitial laser therapy
Laser ablation
Benign
Non-cancerous
Breast lesion
Breast tumor

Additional relevant MeSH terms:
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial