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

Not Applicable

Completed

• Conditions: Patients Requiring Vascular Embolization Alone for Treatment of Malignant Tumors; Patients Requiring Vascular Embolization in the Pre-operative Setting for Treatment of Malignant Tumors; Patients Requiring Vascular Embolization Alone for Treatment of Benign Hypervascular Tumors; Patients Requiring Vascular Embolization in the Pre-operative Setting for Treatment of Benign Hypervascular Tumors; Patients Requiring Vascular Embolization for Select Non-Traumatic End-Organ Infarct; Cancer - Liver; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Cancer - Bone; Cancer - Kidney

• Registration Number: ACTRN12619000536167
• Lead Sponsor: Instylla Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-04
• Study Completion: 2020-08-05
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of serious device and serious procedure-related adverse events and non target embolization. Events will be reviewed by an Independent Medical Monitor. (composite endpoint)<br>There are no known unique risks associated with the Instylla HES. <br>Throughout the duration of the study, subjects will be clinically evaluated (imaging and blood lab tests) and assessed for adverse events 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.[ 90 days post-embolization]

Secondary Outcome Measures

Name	Time	Method
Technical success of achieving embolization demonstrated by post procedure angiography.[ Immediately after embolisation procedure]