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A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers

NCT01478438 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-03

No results posted yet for this study

Summary

This study will determine the rate of complete tumor ablation of small breast cancers (≤ 20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT ablation as correlated to histopathology from the post-ablation excision.

Conditions

  • Malignant Tumor

Interventions

DEVICE

Novilase Interstitial Laser Therapy

Image guided Interstitial Laser Ablation of breast tumors

Sponsors & Collaborators

  • Novian Health Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara Schwartzberg, MD · Rose Medical Center - Rose Breast Center

  • Michael Shere, M.D. · North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-12-31
Completion
2021-08-31

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478438 on ClinicalTrials.gov