American Breast Laser Ablation Therapy Evaluation (ABLATE)
This study is currently recruiting participants.
Verified August 2012 by Novian Health Inc.
Sponsor:
Novian Health Inc.
Information provided by (Responsible Party):
Novian Health Inc.
ClinicalTrials.gov Identifier:
NCT00807924
First received: December 11, 2008
Last updated: August 15, 2012
Last verified: August 2012
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Purpose
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 |
|---|
|
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.:
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807924
Contacts
| Contact: Jessica Topolosky | 312-266-7200 | info@novianhealth.com |
| Contact: Henry Appelbaum | 312-266-7200 |
Locations
| United States, Colorado | |
| Rose Breast Center | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Contact 303-320-7826 | |
| Contact 303-320-7138 | |
| Principal Investigator: John Lewin, MD | |
| Principal Investigator: Barbara Schwartzberg, MD | |
| United States, New York | |
| New York Hospital Queens | Recruiting |
| Flushing, New York, United States, 11355 | |
| Contact 718-670-1185 | |
| Principal Investigator: Margaret Chen, M.D. | |
Sponsors and Collaborators
Novian Health Inc.
Investigators
| Principal Investigator: | John Lewin, MD | Diversified Radiology of Colorado |
| Principal Investigator: | Margaret Chen, MD | New York Hospital Queens |
| Principal Investigator: | Heidi Memmel, MD | Advocate Medical Group |
| Principal Investigator: | Barbara Schwartzberg, MD | 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 |
| Study First Received: | December 11, 2008 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on June 17, 2013