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Instylla HES Hypervascular Tumor Pivotal Study

Sponsor
Instylla, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04523350
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
18.8
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Instylla HES
  • Other: TAE or cTACE
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Instylla HES

Device: Instylla HES
Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG)
Active Comparator: Control

TAE or cTACE

Other: TAE or cTACE
Bland TAE or cTACE
Other Names:
  • Control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary Effectiveness Endpoint: Delivery of the embolic agent to the index tumor feeding vessel with stasis of flow as determined by an independent radiologist via comparison of the pre and final post procedure images [Immediately post-embolization procedure]

      Stasis of flow defined as absence of contrast flow within the targeted tumor feeding vessel

    2. Primary Safety Endpoint: Freedom from major adverse events through 30 days post-index procedure [30 days post-embolization procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female subjects age ≥ 22 years old

    • Subjects with confirmed finding of hypervascular tumor on CT and/or MRI for whom TAE/TACE is medically indicated

    • ECOG PS of 0-2 (PS 0-1 for metastatic disease)

    • Expected life expectancy ≥ 6 months after Index embolization

    Exclusion Criteria:

    • Embolization for lesions other than hypervascular tumors such as arteriovenous malformations

    • Undergoing radioembolization or DEB-TACE for Index Procedure

    • Prior radioembolization of the target tumor lesion/vascular bed

    • For subjects with HCC or undergoing embolization to the liver: Child-Pugh Class C or presence of complete portal vein thrombosis

    • Tumor lesions >8cm in diameter (in one direction) or >50% tumor volume burden of the target organ

    • Any contraindication to arteriography or embolization protocol

    • Pregnant or breast-feeding or females planning on becoming pregnant within the next 3 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alfred Health Melbourne Victoria Australia 3004

    Sponsors and Collaborators

    • Instylla, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Instylla, Inc.
    ClinicalTrials.gov Identifier:
    NCT04523350
    Other Study ID Numbers:
    • INY-P-20-001
    First Posted:
    Aug 21, 2020
    Last Update Posted:
    Feb 12, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Feb 12, 2021