American Breast Laser Ablation Therapy Evaluation
ABLATE
1 other identifier
observational
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 11, 2008
CompletedFirst Posted
Study publicly available on registry
December 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2018
CompletedAugust 4, 2023
August 1, 2023
8.7 years
December 11, 2008
August 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Eligibility Criteria
Patients undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.
You may qualify if:
- 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™
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center - Department of Surgery
New York, New York, 10032, United States
Related Publications (2)
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.
PMID: 19825000BACKGROUNDSchwartzberg 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.
PMID: 30298314BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret Chen, MD
Optum ProHealthcare
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2008
First Posted
December 12, 2008
Study Start
December 1, 2008
Primary Completion
August 28, 2017
Study Completion
August 8, 2018
Last Updated
August 4, 2023
Record last verified: 2023-08