At a glance
ClinicalIndex Comparison RecordN/ACompleted· 44 enrolled
Drug / intervention
Electronic brachytherapy (Axxent System)radiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer
In Brief
A clinical study evaluating Electronic brachytherapy (Axxent System) for Breast Cancer. Completed, enrolled 44 participants across 10 sites.
Detailed Summary
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedNov 2009
Primary CompletionJun 2013
Study CompletionMay 2016
TodayJul 2026
First PostedNov 20, 2009
Enrollment StartMar 26, 2007
Primary CompletionJun 6, 2013
Study CompletionMay 7, 2016
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 16.6 years ago
Interventions
Electronic brachytherapy (Axxent System)radiation
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.