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Instylla HES Hypervascular Tumor Pivotal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523350
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Instylla, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypervascular Tumors Device: Instylla HES Other: TAE or cTACE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 4, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : June 30, 2024

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 Name: Control




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 [ Time Frame: 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 [ Time Frame: 30 days post-embolization procedure ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523350


Contacts
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Contact: Clinical Operations 1 781-790-4860 Clinical@Instylla.com
Contact: Nicole Rissman 781-850-6595 nicoler@instylla.com

Locations
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United States, Alabama
UAB Hospital Recruiting
Birmingham, Alabama, United States, 35233
United States, Arkansas
Central Arkansas Radiation Therapy Institute, Inc. Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697- 7600
Memorial Health Services Recruiting
Long Beach, California, United States, 92708
Olive View-UCLA Education & Research Institute Recruiting
Sylmar, California, United States, 91342-1495
United States, Kentucky
St. Elizabeth Healthcare Recruiting
Edgewood, Kentucky, United States, 41017
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
United States, New Jersey
Summit Health Recruiting
Florham Park, New Jersey, United States, 07932
United States, New York
New York and Presbyterian Hospital (Cornell/Weill Medical College) Recruiting
New York, New York, United States, 10065
United States, North Carolina
Charlotte Radiology Recruiting
Charlotte, North Carolina, United States, 28202
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6061
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Canada, Ontario
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Instylla, Inc.
Investigators
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Principal Investigator: Nadine Abi-Jaoudeh, M.D. University of California, Irvine
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Responsible Party: Instylla, Inc.
ClinicalTrials.gov Identifier: NCT04523350    
Other Study ID Numbers: INY-P-20-001
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes