Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
108 participants
OBSERVATIONAL
2008-12-31
2018-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Hypercellularity suggestive of phyllodes
* Atypia
* Equivocal pathology report (e.g., discordance between radiographic and microscopic results)
* Fibroadenomas with stromal solidarity
18 Years
FEMALE
No
Sponsors
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Novian Health Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Margaret Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Optum ProHealthcare
Locations
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Columbia University Medical Center - Department of Surgery
New York, New York, United States
Countries
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References
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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.
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.
Related Links
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Sponsor website
Other Identifiers
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BR001
Identifier Type: -
Identifier Source: org_study_id
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