N/A
N=44
Post Market Study Using the Xoft Axxent System
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01017549 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With Delivery of 34 Gy in 10 Fractions — 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electronic brachytherapy (Axxent System) (Radiation)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Xoft, Inc.
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Delivery of 34 Gy in 10 Fractions |
42 | — |
| SECONDARY Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. |
— | — |
Summary
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01017549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.