Post Market Study Using the Xoft Axxent System

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.

Key facts

Study ID

NCT01017549

Run by

Xoft, Inc.

People needed

44

Starts

2007-03-26

Expected to finish

2016-05-07

Last updated by the study team

2020-08-13

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age >50 years
• Tumor with Tis, T1, N0, M0 - (AJC Classification)
• Invasive ductal carcinoma or ductal carcinoma in situ
• Negative microscopic surgical margins of at least 1mm in all directions
• Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)

You may not qualify if…

• Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
• Scleroderma, systemic sclerosis and active lupus
• Infiltrating lobular histology

Where it is running

• Mills Peninsula Hospital — San Mateo, California, United States
• Wellstar-Kennestone Cancer Center — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Little Company of Mary Hospital — Evergreen Park, Illinois, United States
• Holy Cross Medical Center — Silver Spring, Maryland, United States
• Beth Israel Medical Center — New York, New York, United States
• Dickstein Cancer Center- White Plains Hospital — White Plains, New York, United States
• Oklahoma University Health Science Center — Oklahoma City, Oklahoma, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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