Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy
NCT01388777 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2018-07-17
Summary
Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue.
The goal of this clinical research study is to learn about the level of effectiveness of using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of this procedure will also be studied.
Conditions
Interventions
- DEVICE
-
Visica 2™ Treatment System
The Visica 2™ Treatment System uses a closed system to circulate liquid nitrogen within the probe tip creating sub-freezing temperatures that result in precision cryoablation of the intended target tissue.
- PROCEDURE
-
Cryoablation
Cryoablation procedure uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The cryoprobe needle insertion is done using ultrasound guide to reach target, procedure lasts about 20 minutes.
- PROCEDURE
-
Surgical Resection
Complete surgical resection of the primary tumor following cryoablation therapy.
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Rosa Hwang, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-24
- Primary Completion
- 2017-06-14
- Completion
- 2017-06-14
Countries
- United States
Study Locations
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