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Instylla HES Hypervascular Tumor Pivotal Study

NCT04523350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-12-16

No results posted yet for this study

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

  • Hypervascular Tumors

Interventions

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

Sponsors & Collaborators

  • Instylla, Inc.

    lead INDUSTRY

Principal Investigators

  • Nadine Abi-Jaoudeh, M.D. · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2024-05-01
Completion
2024-11-19
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523350 on ClinicalTrials.gov