Post Market Study Using the Xoft Axxent System

Xoft

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: Electronic brachytherapy (Axxent System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01017549

1-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Treatment

Other group

Description:

This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment.

Treatment:

Radiation: Electronic brachytherapy (Axxent System)