None listed
Conditions
Brief summary
The Feasibility Study of the ULTRA Embolic Device is intended to study the safety and efficacy of the device in adults 18 years or older who are in need of certain embolic procedures. Efficacy will be measured by observing if the study device is successful at occluding the target vessel at the time of material delivery. The safety of the device will be measured by observing any adverse events at the time of delivery, 24 hours post procedure or time of discharge, at 7 days post procedure, and at 30 days post procedure.
Interventions
Embolisation procedures are peformed in the interventional radiology suite by interventional radiologists and vascular surgeons. Standard of care embolisation procedures involve inserting a small tube (microcatheter) into the patient's arteries and directing it to the area to be occluded. An embolic agent is then delivered through the microcatheter to occlude the target artery. Subjects requiring embolisation of a vascular tumor or blood vessels to occlude blood flow to control bleeding / haemo
Embolisation procedures are peformed in the interventional radiology suite by interventional radiologists and vascular surgeons. Standard of care embolisation procedures involve inserting a small tube (microcatheter) into the patient's arteries and directing it to the area to be occluded. An embolic agent is then delivered through the microcatheter to occlude the target artery. Subjects requiring embolisation of a vascular tumor or blood vessels to occlude blood flow to control bleeding / haemorrhaging in the peripheral vasculature will undergo this type of procedure. The intervenion is the ULTRA Embolic Device. The ULTRA Embolic Device is a hydrogel embolic agent which comes ready to use in a sterile syringe. The physician will deliver the ULTRA Embolic material through the microcatheter until the target artery is blocked. The physician may use more than one syringe if necessary. After occluding the artery, the microcatheter is removed from the patient. The procedure generally lasts 1-2 hours. The intervention will be assessed at the time of the procedure via imaging as well as procedure notes, and then 24 hours post procedure or at patient discharge, 7 days post procedure, and 30 days post procedure via review of patient medical records and patient interviews.
Sponsors
Libble Ginster
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Subject presenting with need for pre-surgical, pre-ablation, or durable embolisation of hypervascular tumours and/or blood vessels to occlude blood flow for controlling bleeding / haemorrhaging in the peripheral vasculature. • Subject is 18 years of age or older with an expected lifespan sufficient to allow for completion of study procedure and follow-up visits.
Exclusion criteria
• Subject’s access vessel(s) preclude safe insertion of delivery catheter or catheter is unable to be advanced to targeted location. • Embolisation for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolisation of arteriovenous shunts, endoleak management, neurovascular bleeds, penetrating trauma of extremities. • Haemorrhagic shock (Class IV) at time of treatment. • Subject has uncorrectable coagulopathies such as thrombocytopenia with platelets <40,000/ µL. • Subject has untreatable allergy to iodinated contrast media or procedural sedatives/anaesthetics. • Subject has vascular anatomy or blood flow that precludes catheter placement or embolic agent delivery, such as: -Presence of persistent, flow-limiting vasospasm that is not responsive to chemical or mechanical interventions -Presence of severe atheromatous disease -Presence of collateral vessel pathways potentially endangering non-target vascular territories during embolisation -Vascular resistance peripheral to the feeding arteries precluding passage of the product -Arteriovenous shunts (i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein) -Presence of patent extra-to-intracranial anastomoses or shunts -Presence of end arteries leading directly to cranial nerves • Use in the pulmonary, coronary, and intracerebral vasculature. • Use in any vasculature where the product could pass directly into the internal carotid artery, vertebral artery, intracranial vasculature.
Outcome results
None listed