Trials / Completed
CompletedNCT01017549
Post Market Study Using the Xoft Axxent System
Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Xoft, Inc. · Industry
- Sex
- Female
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Electronic brachytherapy (Axxent System) | 3.4 Gy per fraction for 10 fractions for a total of 34 Gy. |
Timeline
- Start date
- 2007-03-26
- Primary completion
- 2013-06-06
- Completion
- 2016-05-07
- First posted
- 2009-11-20
- Last updated
- 2020-08-13
- Results posted
- 2011-04-11
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01017549. Inclusion in this directory is not an endorsement.