đź“Š Evidence-Based Reference
eclipse treatment planning system
Varian Medical Systems
Summary: The Eclipse treatment planning system by Varian Medical Systems is a device used in radiotherapy for dose calculation. Key evidence highlights its accuracy in dose computation and the importance of evaluating dosimetric parameters.
FDA Clearance Information
Pathway
510K
Number
K131891 ↗
Decision Date
September 25, 2013
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse treatment planning system was cleared by the FDA via the 510(k) pathway on September 25, 2013. It is manufactured by Varian Medical Systems and is classified as a Class 2 device.
What It Is
The Eclipse treatment planning system is a software device used in radiotherapy to calculate and plan the delivery of radiation doses to patients. It is designed to optimize treatment plans by accurately modeling dose distributions for various radiation modalities.
Clinical Applications
Commonly used in radiotherapy, the Eclipse system is employed in planning treatments for cancer patients, including those with brain cancer. It assists clinicians in determining precise dose distributions to target tumors while sparing healthy tissues.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, spanning from 2022 to 2024. These studies focus on the system's dosimetric accuracy and comparison with other dose calculation methods.
Reported Outcomes
Published studies report that the Eclipse treatment planning system provides accurate dose calculations, particularly in photon and electron therapy. It is effective in evaluating dosimetric parameters in brain cancer radiotherapy and managing uncertainties in electron therapy.
Safety Profile
Reported complications include dose inaccuracies near and inside metal elements due to CT metal artefacts, which can affect treatment planning. The system's accuracy is influenced by the quality of input data and computational algorithms.
Evidence Limitations
Evidence gaps include the need for further research on the system's performance in diverse clinical settings and with different patient populations. Study limitations often involve small sample sizes and the need for more prospective trials.
Frequently Asked Questions
What are the clinical indications for Eclipse treatment planning system?
The Eclipse system is indicated for use in radiotherapy treatment planning, particularly for calculating and optimizing radiation doses for cancer patients.
What outcomes have been reported in clinical studies?
Studies have reported accurate dose calculations and effective management of dosimetric parameters, especially in photon and electron therapies.
What complications have been reported?
Safety data indicate potential dose inaccuracies near metal elements due to CT artefacts, highlighting the importance of accurate input data and algorithm selection.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.