Instylla Hydrogel Embolic System First In Human Study For Patients Requiring Vascular Embolization Alone or in the Pre-operative Setting for Treatment of Malignant and Benign Hypervascular Tumors, and Select Non-Traumatic End-Organ Infarct

A Prospective, Single-arm, Multicenter Study to Evaluate the Safety and Performance of the Instylla Hydrogel Embolic System (HES) For Patients Requiring Vascular Embolization Alone or in the Pre-operative Setting for Treatment of Malignant and Benign Hypervascular Tumors, and Select Non-Traumatic End-Organ Infarct.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000536167

Enrollment

Registered

2019-04-04

Start date

2019-10-22

Completion date

2020-05-19

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will evaluate the safety and performance of the Instylla Hydrogel Embolic System for patients requiring vascular embolisation alone or vascular embolisation for treatment of Malignant and Benign Hypervascular Tumors or non-traumatic end-organ infarct Who is it for? You may be eligible to join this study if you are aged 18 and above and are requiring vascular embolisation alone or vascular embolisation for treatment of Malignant and, or Benign Hypervascular Tumors, or non-traumatic end-organ infarct. 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 90 days post-embolisation. This study will also allow a greater understanding of whether HES can be used to embolise vascular tumours or organs.

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 that will be delivered will be one time and possible more over the 90 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 or oncologist will decide if more procedures are administered.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female patients age greater than or equal to 18 years old 2. Embolization of hypervascular lesion is clinically indicated 3. Expected life expectancy greater than or equal to 6 months after embolization

Exclusion criteria

1. Ongoing adverse effect that may confound the evaluation of the Instylla HES 2. Pregnant or breast-feeding, or females planning on becoming pregnant within the next 6 month 3. The patient has other concurrent conditions 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, renal dysfunction, morbid obesity)

Outcome results