Trials / Completed
CompletedNCT04523350
Instylla HES Hypervascular Tumor Pivotal Study
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
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Instylla, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Instylla HES | Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG) |
| OTHER | TAE or cTACE | Bland TAE or cTACE |
Timeline
- Start date
- 2021-01-04
- Primary completion
- 2024-05-01
- Completion
- 2024-11-19
- First posted
- 2020-08-21
- Last updated
- 2024-12-16
Locations
15 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04523350. Inclusion in this directory is not an endorsement.