đź“Š Evidence-Based Reference
Eclipse Treatment Planning System
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 ?
510(k)
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.
FDA-Cleared Indications
- For use by qualified medical professionals to calculate and plan radiation therapy treatments.
- Supports treatment planning for radiation therapy modalities and treatment techniques described in the cleared labeling.
- Used to model radiation dose distributions to help plan delivery of therapeutic radiation.
Clinical Applications
- Planning external-beam radiation therapy for patients with cancer.
- Calculating dose distributions for treatment plans.
- Evaluating target coverage and radiation dose to surrounding normal tissues.
- Supporting treatment planning for sites such as the brain and other anatomic regions treated with external-beam radiation.
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.
Practical Considerations
- Eclipse is software, not an implantable or disposable device, so it does not have a physical device size or vessel compatibility profile.
- Treatment plans require review and approval by qualified radiation oncology professionals before delivery.
- Dose calculations and plan quality depend on accurate patient imaging, anatomical modeling, treatment-machine data, and appropriate commissioning and quality assurance.
- MRI images may be used for treatment planning when appropriately registered with planning CT or other required imaging; MRI safety applies to the scanner and accessories, not to Eclipse software itself.
- The system is not a substitute for clinical judgment, treatment verification, or required radiation safety and quality-control procedures.
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.