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decimal bolus
.Decimal
Summary: The decimal bolus by .Decimal is a clinician-facing device used primarily in intensity-modulated bolus electron conformal therapy. Key evidence highlights its dosimetric accuracy and potential complications in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K211511 ↗
Decision Date
July 1, 2021
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The decimal bolus was cleared by the FDA through the 510k pathway on July 1, 2021. It is manufactured by .Decimal and classified as a Class 2 device.
What It Is
The decimal bolus is a device used in radiation therapy to modulate electron beams for conformal treatment. It is designed to enhance dose distribution accuracy in clinical applications such as electron conformal therapy.
Clinical Applications
Commonly used in scenarios requiring precise electron beam modulation, the decimal bolus is applied in treatments like total scalp irradiation and intensity-modulated electron therapy. It aids in achieving targeted dose delivery while minimizing exposure to surrounding tissues.
Evidence Summary
The literature includes 15 studies ranging from 2021 to 2024, encompassing various study types such as RCTs and retrospective analyses. These studies explore the device's dosimetric performance and clinical applications.
Reported Outcomes
Published studies report that the decimal bolus improves dose distribution in electron conformal therapy, with evidence supporting its use in intensity-modulated treatments. However, some studies highlight challenges in achieving uniform dose delivery, particularly in complex anatomical regions.
Safety Profile
Reported complications include a high risk of osteoradionecrosis in high-dose single-fraction electron FLASH-RT, as noted in veterinary clinical trials. Other studies did not report significant adverse events directly attributed to the device.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term outcome data. Further research is needed to validate findings in diverse patient populations and to optimize treatment protocols using the decimal bolus.
Frequently Asked Questions
What are the clinical indications for decimal bolus?
The decimal bolus is indicated for use in intensity-modulated electron conformal therapy, particularly in scenarios requiring precise dose modulation.
What outcomes have been reported in clinical studies?
Studies have reported improved dose distribution and treatment precision, although challenges in achieving uniform dose delivery remain.
What complications have been reported?
Safety data indicate a risk of osteoradionecrosis in high-dose settings, with no significant adverse events reported in other contexts.
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.