American Breast Laser Ablation Therapy Evaluation (ABLATE)

American Breast Laser Ablation Therapy Evaluation (ABLATE): Monitoring the Long Term Safety and Efficacy of Novilase™ Breast Interstitial Laser Therapy in Real World Application

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.

Study Overview

• Status: Completed
• Conditions: Benign Breast Conditions; Breast Fibroadenomas

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.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center - Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novian Health Inc.
• Investigators: Principal Investigator: Margaret Chen, MD, Optum ProHealthcare

Publications and helpful links

General Publications

• 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.

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 8, 2018

Study Registration Dates

• First Submitted: December 11, 2008
• First Submitted That Met QC Criteria: December 11, 2008
• First Posted (Estimated): December 12, 2008

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Breast; Benign; Minimally invasive; Laser ablation; Breast tumor; Fibroadenomas; Papillomas; Interstitial laser therapy; Non-cancerous; Breast lesion
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Fibroepithelial; Fibroadenoma
• Other Study ID Numbers: BR001