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Onyx, TRUFILL

Phase 2

Brain Arteriovenous Malformations | Unknown | Other |Medtronic plc.|Last Updated: Oct 27, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment117

FDA Designations

No designations recorded

Clinical trial landscape

Onyx, TRUFILL · 1 trial · 1 indication

Phase 2 1
NCT00857662Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)Brain Arteriovenous Malformations
COMPLETED117 Analytics
PHASE2COMPLETED
Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)
Brain Arteriovenous MalformationsUnlock trial analytics

Study Endpoints

Primary Endpoints

Angiographic reduction in AVM size (volume) of 50% or greater, where angiographic size reduction is defined as the change from the original AVM size prior to any embolization procedure, to the AVM size after the last embolization.
Post final embolization

Secondary Endpoints

Safety will be assessed by the nature and severity of adverse events
3 months post discharge
Surgical blood loss
Surgical resection time
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OnyxEXPERIMENTAL -
TRUFILLACTIVE_COMPARATOR -

Interventions

NameTypeDescription
OnyxDEVICEEmbolization
TRUFILLDEVICEEmbolization
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * The patient or patient's guardian understands and will sign the informed consent for the procedure * The patient has a confirmed diagnosis of a brain AVM in the cerebral cortex, cerebellum or dura mater as visualized by angiography or cross sectional imaging. * The brain AVM h...

Countries:United States
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Frequently asked questions about Onyx, TRUFILL

What is Onyx, TRUFILL used for in Brain Arteriovenous Malformations?

Onyx and TRUFILL are liquid embolic agents used to treat brain arteriovenous malformations (AVMs), abnormal tangles of blood vessels in the brain. They are injected into the malformation to block blood flow. Both are being studied in a Phase 2 clinical trial for this condition.

Who makes Onyx, TRUFILL?

Onyx and TRUFILL are developed by Medtronic plc., a medical technology company. Medtronic is publicly traded on the New York Stock Exchange under the ticker symbol MDT.

What phase is Onyx, TRUFILL in?

Onyx and TRUFILL are in Phase 2 clinical development for brain arteriovenous malformations. The Phase 2 trial has been completed. They are investigational agents and have not been approved for this indication based on the available data.

What clinical trials is Onyx, TRUFILL in?

Onyx and TRUFILL are being evaluated in a completed Phase 2 clinical trial with the identifier NCT00857662. The study, titled "Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)," enrolled 117 participants in the United States and used an active-controlled design.

Is Onyx the same as TRUFILL?

Onyx and TRUFILL are two different liquid embolic agents being compared against each other in a clinical trial for brain arteriovenous malformations. The trial is designed to compare the two treatments directly, indicating they are distinct products with potentially different characteristics.