At a glance
ClinicalIndex Comparison RecordN/ACompleted· 150 enrolled / 150 target
Drug / intervention
Instylla HES +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Instylla HES and TAE or cTACE for Hypervascular Tumors. Completed, enrolled 150 participants across 15 sites in 2 countries.
Signals
Enrolling slower than its timeline implies
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypervascular Tumors
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartMar 2021
Primary CompletionMay 2024
Study CompletionNov 2024
TodayJul 2026
First PostedAug 21, 2020
Enrollment StartMar 5, 2021
Primary CompletionMay 1, 2024
Study CompletionNov 19, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.9 years ago
Arms & Interventions
Instylla HESexperimental
Device: Instylla HES
Controlactive_comparator
TAE or cTACE
Other: TAE or cTACE
Interventions
Instylla HESdevice
Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG)
TAE or cTACEother
Bland TAE or cTACE