Post Market Study Using the Xoft Axxent System
- Conditions
- Breast Cancer
- Registration Number
- NCT01017549
- Lead Sponsor
- Xoft, Inc.
- Brief Summary
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
- Detailed Description
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Participants With Delivery of 34 Gy in 10 Fractions measured at end of 10th fraction, usually within 7 days Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)
- Secondary Outcome Measures
Name Time Method Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. Through 6 months Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported.
Trial Locations
- Locations (10)
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
Mills Peninsula Hospital🇺🇸San Mateo, California, United States