Instylla HES Hypervascular Tumor Pivotal Study

Hypervascular Tumors Clinical Trial

Official title: Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared With Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study

Status Active, not recruiting

Clinical Trial Summary

To determine whether Instylla HES has the ability to effectively embolize targeted arterial segments of hypervascular tumors as well as (i.e., is non-inferior to) standard of care (SOC) transarterial embolization/conventional transarterial chemoembolization, while resulting in an acceptable risk of device and procedure-related serious adverse events.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hypervascular Tumors

• NCT number: NCT04523350
• Study type: Interventional
• Source: Instylla, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2021
• Completion date: September 30, 2024