First in Human Feasibility Study of Pre-Surgical Embolisation of Hypervascular Extra-axial Brain Tumours with the Arsenal Medical Distal Penetrating Embolic System (DPE) to evaluate initial Safety and Performance.

Arsenal Medical Australia Pty Ltd,0 个研究点目标入组 5 人开始时间: 2022年6月9日最近更新: 2024年3月4日

适应症

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•Screening Inclusion Criteria:
•Participant whose age is between 18 and 80 years;
•Participant whose baseline mRS score is less than or equal to 2;
•Contrast enhancing extra-axial supratentorial brain tumour measuring between 2.5 cm and 6 cm in the greatest diameter;
•Participant planned for pre-operative embolisation followed by neurological assessment, and subsequent surgical resection under a separate general anesthesia protocol within the next 7 days;
•Participant understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form;
•Participant (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an effective method of contraception throughout the study;
•Participant is willing to return to or call the investigational site for 30-day and 90-day follow-ups.
•Baseline Inclusion Criteria:
•Digital subtractive angiography (DSA) demonstrates a hypervascular tumour blush supplied by branches of the middle meningeal artery which both originates from the external carotid artery and is amenable to catheterisation with a standard microcatheter
•A negative pregnancy test is required at baseline for a woman of child-bearing potential

•Screening Exclusion Criteria:
•Tumours originating from the skull base except lateral sphenoid wing
•Participant who is breastfeeding
•Participant with life expectancy of less than 1 year
•Prior embolisation, radiation therapy, or surgical treatment of the tumour
•Participants with renal impairment that the investigator assesses could be at risk for contrast induced nephropathy
•Participant with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
•Participant is allergic to any of the materials used in the DPE device
•Participant who is currently participating or planning to participate within 3 months in another non-observational clinical research study
•Baseline Exclusion Criteria:
•Digital subtractive angiography (DSA) demonstrates vasculature not amenable to catheterisation or embolisation including high-risk anastomoses with eloquent arteries

发起方

Arsenal Medical Australia Pty Ltd,