Clinical trial · Observational
American Breast Laser Ablation Therapy Evaluation
American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application
NCT00807924CI-TRIAL-00068527ABLATEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Breast Conditions; Breast Fibroadenomas | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- To monitor and measure long term safety and effectiveness Novilase
- timeFrame
- ongoing
- measure
- To help refine, improve and/or validate breast tumor best practices and standard of care
- timeFrame
- ongoing
- measure
- To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols
- timeFrame
- ongoing
- measure
- 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
- timeFrame
- ongoing
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDDowlatshahi 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 19825000
- BACKGROUNDSchwartzberg 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 30298314