Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery
NCT05028400
AVM, Aneurysm
Bern, Switzerland
View Trial DetailsNCT Number: NCT03317821
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
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Notify Me18 year and older
All sexes
Observational
Rigshospitalet University, Copenhagen, Denmark
This is an European multi-center observational study. Treatments and follow-up visits will be done as per standard of care.
The objective of this study is to evaluate the efficacy and safety of the PHIL® device in the treatment of intracranial dural ArterioVenous Fistula (dAVF). The PHIL® device, a non-adhesive liquid embolic agent, has been CE marked since July 2014. It is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.
All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 70 patients will be enrolled in this study in 16 European Institutions.
The expected approximate study duration is 38 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 month
Neurological assessment by mRS
Time frame: 3-6 months after last embolization
Cure rate assessment by Angiography
Time frame: 3-6 months after last embolization
Neurological assessment by mRS
Time frame: 3-6 months after last embolization
Assessed by Quality of Life Questionnaire EQ 5D
Microvention-Terumo, Inc.
Industry
PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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