Breast Cancer Clinical Trial

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American Breast Laser Ablation Therapy Evaluation

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Summary

The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilaseâ„¢ device and method in real world application.

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Full 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.

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Eligibility 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 Novilaseâ„¢

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

200

Study ID:

NCT00807924

Recruitment Status:

Unknown status

Sponsor:

Novian Health Inc.

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There is 1 Location for this study

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Columbia University Medical Center - Department of Surgery
New York New York, 10032, United States More Info
Margaret Chen, M.D.
Contact
212-305-9676
Margaret Chen, M.D.
Principal Investigator
Sheldon Feldman, M.D.
Sub-Investigator
Bret Taback, M.D.
Sub-Investigator
Preya Ananthakrishnan, M.D.
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

200

Study ID:

NCT00807924

Recruitment Status:

Unknown status

Sponsor:


Novian Health Inc.

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
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