Clinical trial · Interventional
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
NCT01017549CI-TRIAL-00046623completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic brachytherapy (Axxent System) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment.
- interventionNames
- Radiation: Electronic brachytherapy (Axxent System)
Primary outcomes (1)
- measure
- Number of Participants With Delivery of 34 Gy in 10 Fractions
- timeFrame
- measured at end of 10th fraction, usually within 7 days
- description
- 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 outcomes (1)
- measure
- Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMehta VK, Algan O, Griem KL, Dickler A, Haile K, Wazer DE, Stevens RE, Chadha M, Kurtzman S, Modin SD, Dowlatshahi K, Elliott KW, Rusch TW. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010 Aug;33(4):327-35. doi: 10.1097/COC.0b013e3181d79d9e. PMID 20375833