Clinical trial NCT00807924: American Breast Laser Ablation Therapy Evaluation
Official title: American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Breast Conditions; Breast Fibroadenomas
Keywords: Fibroadenomas
Papillomas
Breast
Minimally invasive
Interstitial laser therapy
Laser ablation
Benign
Non-cancerous
Breast lesion
Breast tumor
Lead sponsor: Novian Health Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-12
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.

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.

Detailed 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.

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 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center - Department of Surgery
state: New York
Study officials:
affiliation: Optum ProHealthcare
name: Margaret Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.