American Breast Laser Ablation Therapy Evaluation

Benign Breast Conditions; Breast Fibroadenomas Clinical Trial

— ABLATE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807924
• Other study ID #: BR001
• Status: Completed
• Start date: December 2008
• Est. completion date: August 8, 2018

Study information

• Verified date: August 2023
• Source: Novian Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 8, 2018
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Breast Conditions; Breast Fibroadenomas
• Fibroadenoma

Locations

Country	Name	City	State
United States	Columbia University Medical Center - Department of Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novian Health Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To monitor and measure long term safety and effectiveness Novilase		ongoing
Primary	To help refine, improve and/or validate breast tumor best practices and standard of care		ongoing
Primary	To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols		ongoing
Primary	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

External Links

•   Sponsor website