None listed
Conditions
Brief summary
This study will evaluate the safety and performance of the Instylla Hydrogel Embolic System for patients requiring vascular embolisation for treatment of bleeds. Who is it for? You may be eligible to join this study if you are aged 18 and above and are requiring vascular embolisation for treatment of bleeds. Study details All participants will receive vascular embolisation using the Instylla Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter. Safety and performance of the HES will be assessed using using the grading of the NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0). Severity of complications will be further classified in accordance with Society of Interventional Radiology (SIR) guidelines. for up to 30 days post-embolisation. This study will also allow a greater understanding of whether HES can be used to embolise vascular bleeds.
Interventions
Instylla Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter.
This involvement for the patient is the same procedures, activities and processes used for standard vascular embolization procedures.
Subjects will be treated within this protocol by an interventionalist with substantial prior experience with vascular embolization procedure.
The mode of delivery will be performed face to face and the location will be at the hospital.
The number of interventions tha
Instylla Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter. This involvement for the patient is the same procedures, activities and processes used for standard vascular embolization procedures. Subjects will be treated within this protocol by an interventionalist with substantial prior experience with vascular embolization procedure. The mode of delivery will be performed face to face and the location will be at the hospital. The number of interventions that will be delivered will be one time and possible more over the 30 day follow-up period. The procedure will take about the same time as a standard embolic procedure (about 30 minutes to an hour). The interventionalist will decide if more procedures are administered.
Sponsors
Instylla Inc
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients age greater than or equal to 18 years old 2. Transcatheter vascular embolization of vascular bleeds is clinically indicated 3. Positive angiographic findings of bleeding
Exclusion criteria
1. Ongoing adverse effect that may confound the evaluation of the Instylla HES 2. Pregnant females 3. The patient has other concurrent conditions or known history that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives (including but not limited to ongoing infection, morbid obesity).
Outcome results
None listed