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

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 Overview

• Status: Completed
• Conditions: Hypervascular Tumors
• Intervention / Treatment: Device: Instylla HES; Other: TAE or cTACE

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
    • Toronto, Ontario, Canada, M5G 1Z5
      • Mount Sinai
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Hospital
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Radiation Therapy Institute, Inc.
  • California
    • Irvine, California, United States, 92697- 7600
      • University of California, Irvine
    • Long Beach, California, United States, 92708
      • Memorial Health Services
    • Sylmar, California, United States, 91342-1495
      • Olive View-UCLA Education & Research Institute
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Health
  • New York
    • New York, New York, United States, 10065
      • New York and Presbyterian Hospital (Cornell/Weill Medical College)
  • North Carolina
    • Charlotte, North Carolina, United States, 28202
      • Charlotte Radiology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-6061
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects age ≥ 22 years old

2. Subjects with confirmed finding of hypervascular tumor on CT and/or MRI for whom TAE or cTACE is medically indicated, including but not limited to:

   1. Subjects with unresectable primary or metastatic hepatic cancer
   2. Subjects with primary, metastatic or benign renal tumors
   3. Subjects with bone metastases
   4. Subjects with adrenal tumors
   5. Subjects with other hypervascular tumors
3. Subjects with at least one target lesion that is well-delineated such that, in the Investigator's opinion, the lesion can be measured in at least one dimension as 1 cm or more, suitable for remeasurement, and demonstrating definitive arterial enhancement (Note: Pre-operative tumors do not need to meet this criterion.)
4. Subjects with at least one target vessel ≤ 5mm and Instylla HES can be delivered to the target vessel(s).
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 (PS 0-1 for metastatic disease)
6. Subject or authorized representative have been informed of the nature of the study and has provided written informed consent approved by the appropriate local Ethics Committee/Institutional Review Board and agrees to comply with all protocol specified follow-up appointments.
7. Expected life expectancy ≥ 6 months after Index embolization

Exclusion Criteria:

1. Embolization for lesions other than hypervascular tumors such as arteriovenous malformations.
2. It is anticipated that not all target vessels requiring embolization during the index procedure can be embolized with either HES alone or the SOC embolization agent as assigned.
3. Undergoing radioembolization or DEB-TACE for Index Procedure
4. Undergoing a planned secondary procedure the same day as the Index Procedure
5. Requires TAE/cTACE for liver tumors via extrahepatic collateral artery(ies)
6. Prior radioembolization of the target tumor lesion/vascular bed within 30 days of the Index Procedure.
7. For subjects with HCC or undergoing embolization to the liver: Child-Pugh Class C or presence of complete portal vein thrombosis.
8. Tumor lesions > 8 cm in diameter (in one direction) or >50% tumor volume burden of the target organ
9. If subject was treated with Avastin, last dose is within 4 weeks of the planned procedure.
10. Known severe atheromatosis or vascular anatomy that precludes catheterization
11. Presence of bilioenteric anastomoses and/or prior biliary stenting/drainage or any violation of the biliary sphincter, including sphincterotomy for embolization of liver tumors
12. Target lesion supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway
13. Known allergies (based on history) to PEG, ferrous compounds, tert Butyl Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not amenable to pre-medication
14. Uncorrectable impaired clotting: Platelet count <30,000/µL or International Normalized Ratio (INR) > 1.5
15. Serum creatinine > 2 mg/dL
16. Serum bilirubin level > 3 mg/dL
17. Serum albumin < 2.5 g/dL
18. Any contraindication to angiography or embolization protocol utilized at treating institution.
19. Pregnant or breast-feeding or females planning on becoming pregnant with the next 3 months (women of child-bearing potential must undergo a pregnancy test performed in accordance with local institutional requirements).
20. Other concurrent conditions including an ongoing adverse effect or complication of prior therapy or adverse drug reactions, that in the opinion of the Investigator or Clinical Events Committee, would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise subject safety or study objectives (including but not limited to ongoing acute infection, renal dysfunction, morbid obesity, severe cardiac disease).
21. Enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Stasis of flow defined as absence of contrast flow within the targeted tumor feeding vessel	Immediately post-embolization procedure
Primary Safety Endpoint: Freedom from major adverse events through 30 days post-index procedure		30 days post-embolization procedure

Collaborators and Investigators

• Sponsor: Instylla, Inc.
• Investigators: Principal Investigator: Nadine Abi-Jaoudeh, M.D., University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: INY-P-20-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes