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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| To monitor and measure long term safety and effectiveness Novilase | ongoing | |
| To help refine, improve and/or validate breast tumor best practices and standard of care | ongoing | |
| To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols | ongoing | |
| 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 | ongoing |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Chen, MD | Optum ProHealthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center - Department of Surgery | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19825000 | Background | Dowlatshahi K, Wadhwani S, Alvarado R, Valadez C, Dieschbourg J. Interstitial laser therapy of breast fibroadenomas with 6 and 8 year follow-up. Breast J. 2010 Jan-Feb;16(1):73-6. doi: 10.1111/j.1524-4741.2009.00830.x. Epub 2009 Oct 12. | |
| 30298314 | Background | Schwartzberg B, Lewin J, Abdelatif O, Bernard J, Bu-Ali H, Cawthorn S, Chen-Seetoo M, Feldman S, Govindarajulu S, Jones L, Juette A, Kavia S, Maganini R, Pain S, Shere M, Shriver C, Smith S, Valencia A, Whitacre E, Whitney R. Correction to: Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations. Ann Surg Oncol. 2018 Dec;25(Suppl 3):998. doi: 10.1245/s10434-018-6861-3. |
| Label | URL |
|---|---|
| Sponsor website | View source |
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| ID | Term |
|---|---|
| D018226 | Fibroadenoma |
| D010212 | Papilloma |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018307 | Neoplasms, Squamous Cell |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |