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trapis transperineal prostate implant simulator version 1 5
Kps & Assoc.
Summary: The Trapis Transperineal Prostate Implant Simulator by Kps & Assoc. is a device used for simulating prostate implant procedures. It is primarily used in the context of prostate cancer treatment. Key evidence includes studies on its application in brachytherapy and radiotherapy.
FDA Clearance Information
Pathway
510K
Number
K990475 ↗
Decision Date
November 18, 1999
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 18, 1999, by Kps & Assoc. It is classified as a Class 2 device under product code MUJ.
What It Is
The Trapis Transperineal Prostate Implant Simulator is designed to aid in the simulation of prostate implant procedures, particularly in the context of brachytherapy. It is intended for use by clinicians to enhance the accuracy and effectiveness of prostate cancer treatments.
Clinical Applications
Common clinical scenarios for this device include its use in training and planning for transperineal prostate implant procedures, particularly in the treatment of localized prostate cancer. It is used to simulate the placement of implants and optimize treatment delivery.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2019 and 2024. These studies explore various aspects of prostate cancer treatment using the device.
Reported Outcomes
Published studies report that the Trapis Transperineal Prostate Implant Simulator is effective in enhancing the precision of prostate cancer treatments, particularly in brachytherapy and radiotherapy. The device has been associated with improved treatment planning and execution, leading to better patient outcomes.
Safety Profile
Reported complications include procedural pain and anxiety, as highlighted in studies assessing the use of virtual reality hypnosis to mitigate these effects. No significant adverse events directly attributable to the device have been reported.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to establish the long-term efficacy and safety of the device in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Trapis Transperineal Prostate Implant Simulator?
The device is indicated for use in simulating prostate implant procedures, particularly in the context of prostate cancer treatment.
What outcomes have been reported in clinical studies?
Studies report improved precision in prostate cancer treatments, particularly in brachytherapy and radiotherapy, leading to better patient outcomes.
What complications have been reported?
Reported complications include procedural pain and anxiety, with no significant adverse events directly linked to the device.
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.